Product Code: DHB FDA class 2 21 CFR 866.5750

System, Test, Radioallergosorbent (Rast) Immunological

Immunology

The Radioallergosorbent (RAST) Immunological Test System is a laboratory assay used to identify and quantify allergen-specific IgE antibodies in patient serum, supporting the diagnosis and management of allergic conditions. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5750 within the Immunology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

266

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DHB in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DHB
Device Class: FDA class 2
Regulation Number: 866.5750
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 266 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260280	NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg	Jun 18, 2026	Substantially Equivalent	Hycor Biomedical
K260059	NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)	May 15, 2026	Substantially Equivalent	Hycor Biomedical
K252775	NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg	Jan 16, 2026	Substantially Equivalent	Hycor Biomedical
K252493	NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)	Dec 23, 2025	Substantially Equivalent	Hycor Biomedical
K242531	NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz	Apr 23, 2025	Substantially Equivalent	Hycor Biomedical
K212181	ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed	Aug 03, 2022	Substantially Equivalent	Phadia AB
K220162	Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria	Feb 18, 2022	Substantially Equivalent	Hycor Biomedical
K193613	Allergen-Specific IgE Assay 12 Allergen Bundle	Oct 18, 2021	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K200825	NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense	Jun 26, 2020	Substantially Equivalent	Hycor Biomedical
K200279	ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine	May 01, 2020	Substantially Equivalent	Phadia AB
K191510	Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae	Jul 31, 2019	Substantially Equivalent	Hycor Biomedical
K190315	ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat	May 14, 2019	Substantially Equivalent	Phadia AB
K182793	AP3600 Automated Instrument	Mar 19, 2019	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K182479	NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus	Dec 04, 2018	Substantially Equivalent	Hycor Biomedical
K173726	ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut	Apr 16, 2018	Substantially Equivalent	Phadia AB
K163370	ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE	May 05, 2017	Substantially Equivalent	Phadia AB
K150597	ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite	Feb 29, 2016	Substantially Equivalent	Phadia AB
K151029	Phadia Prime	Jan 19, 2016	Substantially Equivalent	Phadia AB
K150854	ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut	Dec 14, 2015	Substantially Equivalent	Phadia AB
K132801	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY	May 28, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K122197	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES	Aug 28, 2013	Substantially Equivalent	Phadia US, Inc.
K131738	IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H	Jul 10, 2013	Substantially Equivalent	Phadia AB
K123275	IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM	Jun 28, 2013	Substantially Equivalent	Phadia AB
K121156	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES	Mar 13, 2013	Substantially Equivalent	Phadia AB
K121463	IMMUNOCAP ALLERGEN K82	Jan 29, 2013	Substantially Equivalent	Thermo Fisher Scientific
K112910	AP 72OS SEMI-AUTOMATED INSTRUMENT	Dec 20, 2012	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K113841	IMMUNOCAP ALLERGEN COMPONENTS BUNDLE	Sep 13, 2012	Substantially Equivalent	Phadia US, Inc.
K112523	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Jan 06, 2012	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K111919	IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS	Dec 22, 2011	Substantially Equivalent	Phadia US, Inc.
K101572	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Aug 01, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K101251	IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN	May 27, 2011	Substantially Equivalent	Phadia AB
K100910	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6	May 11, 2011	Substantially Equivalent	Siemens Medical Solutions Diagnostics
K093987	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6	Mar 28, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K100999	IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01	Dec 15, 2010	Substantially Equivalent	Phadia AB
K093107	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Sep 30, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K092978	IMMUNOCAP RAPID READER, MODEL 12-3600-10	Jan 19, 2010	Substantially Equivalent	Phadia US, Inc.
K092050	IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01	Nov 20, 2009	Substantially Equivalent	Phadia AB
K091984	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6	Oct 28, 2009	Substantially Equivalent	Siemens Medical Solutions Diagnostics
K091289	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Aug 06, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K090257	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	May 26, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K083853	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Mar 24, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K081830	IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1	Mar 16, 2009	Substantially Equivalent	Phadia AB
K083314	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Mar 11, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K081217	HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM	May 22, 2008	Substantially Equivalent	Hycor Biomedical, Inc.
K080322	HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200	Mar 05, 2008	Substantially Equivalent	Hycor Biomedical, Inc.
K071913	IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01	Aug 24, 2007	Substantially Equivalent	Phadia AB
K051677	OPTIGEN ALLERGEN SPECIFIC IGE ASSAY	Jan 23, 2006	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K051218	MODIFICATION TO: UNICAP SPECIFIC IGE	Jun 09, 2005	Substantially Equivalent	Pharmacia Diagnostics AB
K030590	CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)	Mar 21, 2003	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K023152	IMMULITE 2000 ALLERGEN-SPECIFIC IGE	Dec 17, 2002	Substantially Equivalent	Diagnostic Products Corp.
K021208	IMMULITE 2000 MIXED ALLERGEN PANELS	May 30, 2002	Substantially Equivalent	Diagnostic Products Corp.
K021206	IMMULITE 2000 SPECIFIC ALLERGENS	May 30, 2002	Substantially Equivalent	Diagnostic Products Corp.
K020387	MYALLERGYTEST SYSTEM	Apr 17, 2002	Substantially Equivalent	Immunetech Corporation
K013135	IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)	Oct 19, 2001	Substantially Equivalent	Diagnostic Products Corp.
K013134	IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)	Oct 15, 2001	Substantially Equivalent	Diagnostic Products Corp.
K000132	ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8	Feb 18, 2000	Substantially Equivalent	Pharmacia & Upjohn Co.
K993388	ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F	Dec 01, 1999	Substantially Equivalent	Pharmacia & Upjohn Co.
K991048	ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2	May 14, 1999	Substantially Equivalent	Pharmacia & Upjohn Co.
K983954	ALASTAT MICROPLATE MIXED ALLERGEN PANELS	Dec 17, 1998	Substantially Equivalent	Diagnostic Products Corp.
K982343	ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3	Sep 15, 1998	Substantially Equivalent	Pharmacia & Upjohn Co.
K974580	ALLERGEN IMMUNOCAP F256,F245,F207,F202	Feb 09, 1998	Substantially Equivalent	Pharmacia & Upjohn Co.
K974350	ALLERGAN IMMUNO CAP M4, M8, K70	Feb 09, 1998	Substantially Equivalent	Pharmacia, Inc.
K973186	IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE	Sep 29, 1997	Substantially Equivalent	Diagnostic Products Corp.
K972364	UNICAP PHADIATOP	Sep 04, 1997	Substantially Equivalent	Pharmacia, Inc.
K972068	UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82	Jul 03, 1997	Substantially Equivalent	Pharmacia, Inc.
K965094	HYCOR ALLERGEN DISC	May 21, 1997	Substantially Equivalent	Hycor Biomedical, Inc.
K962976	PHARMACIA CAP SYSTEM RAST FEIA	Dec 23, 1996	Substantially Equivalent	Pharmacia & Upjohn Co.
K963245	IMMULITE LATEX-SPECIFIC IGE	Nov 18, 1996	Substantially Equivalent	Diagnostic Products Corp.
K961889	SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS	Oct 10, 1996	Substantially Equivalent	Diagnostic Products Corp.
K962274	UNICAP 100	Sep 12, 1996	Substantially Equivalent	Pharmacia, Inc.
K941993	PHARMACIA CAP SYSTEM PHADIATOP FEIA	Jan 30, 1996	Substantially Equivalent	Pharmacia, Inc.
K954566	SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM	Dec 18, 1995	Substantially Equivalent	Diagnostic Products Corp.
K953780	ACCESS ALLERGEN DOG EPITHELIM	Nov 14, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K950728	QUICKVUE ONE-STEP ALLERGEN SCREEN	Oct 02, 1995	Substantially Equivalent	Quidel Corp.
K953014	ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN	Aug 15, 1995	Substantially Equivalent	Diagnostic Products Corp.
K945884	SPECIFIC IGE ULTRA-EIA	Jun 30, 1995	Substantially Equivalent	Hycor Biomedical, Inc.
K945748	HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY	Jun 07, 1995	Substantially Equivalent	Hycor Biomedical, Inc.
K950629	ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR	May 23, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K931746	LATEX (K82)	Mar 21, 1995	Substantially Equivalent	Diagnostic Products Corp.
K941278	HY-TEC AUTOMATED EIA SYSTEM	Mar 13, 1995	Substantially Equivalent	Hycor Biomedical, Inc.
K943768	HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT	Mar 06, 1995	Substantially Equivalent	Diagnostic Products Corp.
K941057	SPECIFIC IGE EIA-ULTRA ASSAY	Jan 20, 1995	Substantially Equivalent	Hycor Biomedical, Inc.
K941564	IMMULITE ALATOP ALLERGY SCREEN	Dec 19, 1994	Substantially Equivalent	Diagnostic Products Corp.
K935488	ALATOP(R) MICROPLATE ALLERGY SCREEN	Mar 22, 1994	Substantially Equivalent	Diagnostic Products Corp.
K935876	ACCESS SPECIFIC IGE ASSAY	Mar 11, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K934524	MAST CLA ALLERGY SYSTEM	Mar 07, 1994	Substantially Equivalent	Mast Immunosystems
K926420	MAST CLA ALLERGY SYSTEM	Mar 07, 1994	Substantially Equivalent	Mast Immunosystems
K925044	VENTREX ALLERGEN DISC	May 14, 1993	Substantially Equivalent	Ventrex, Inc.
K923420	CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY	Feb 23, 1993	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K925425	SPECIFIC IGE EIA-TURBO ASSAY	Jan 14, 1993	Substantially Equivalent	Hycor Biomedical, Inc.
K924044	VENTREX ALLERGEN DISC	Dec 01, 1992	Substantially Equivalent	Hycor Biomedical, Inc.
K924209	VENTREX ALLERGEN DISC	Nov 30, 1992	Substantially Equivalent	Hycor Biomedical, Inc.
K924119	VENTREX ALLERGEN DISC	Nov 30, 1992	Substantially Equivalent	Ventrex, Inc.
K923284	BASELINE CALIBRATION VERIFICATION CONTROLS	Sep 28, 1992	Substantially Equivalent	Hycor Biomedical, Inc.
K914685	866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS	Sep 14, 1992	Substantially Equivalent	In Vitro Technologies, Inc.
K914959	MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM	Aug 20, 1992	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K921574	WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC	Aug 03, 1992	Substantially Equivalent	Hycor Biomedical, Inc.
K922538	VENTREX ALLERGEN DISC	Jul 27, 1992	Substantially Equivalent	Hycor Biomedical, Inc.
K914554	SPECIFIC IGE EIA-TURBO ASSAY	Mar 13, 1992	Substantially Equivalent	Ventrex Laboratories, Inc.
K913833	VENTREX ALLERGEN DISC	Feb 21, 1992	Substantially Equivalent	Ventrex Laboratories, Inc.
K914850	CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE	Dec 09, 1991	Substantially Equivalent	Mast Immunosystems
K913150	ABBOTT MATRIX AERO PLUS SYSTEM	Nov 29, 1991	Substantially Equivalent	Abbott Laboratories
K913212	3M IGE SINGLE POINT FAST TEST	Nov 22, 1991	Substantially Equivalent	Whittaker Bioproducts, Inc.
K912294	ALLERGY INFORMATION MANAGER	Nov 22, 1991	Substantially Equivalent	Diagnostic Products Corp.
K913892	FASTTECH SYSTEM II	Oct 02, 1991	Substantially Equivalent	3M Diagnostic Systems, Inc.
K911903	ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA	Aug 12, 1991	Substantially Equivalent	Pharmacia, Inc.
K912582	MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM	Jul 31, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K894227	ALLERGEN MODULES FOR ALASTAT TM	Apr 17, 1991	Substantially Equivalent	Diagnostic Products Corp.
K910292	MAST CLA ALLERGY SYSTEM	Apr 05, 1991	Substantially Equivalent	Mast Immunosystems
K905054	CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER	Mar 22, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K910517	CAP SYSTEM RAST ASM/RIA AND ASM/FEIA	Mar 05, 1991	Substantially Equivalent	Pharmacia, Inc.
K905636	VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY	Feb 07, 1991	Substantially Equivalent	Ventrex Laboratories, Inc.
K910075	SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE	Jan 30, 1991	Substantially Equivalent	Diagnostic Products Corp.
K905162	QUIDEL TOTAL IGE POSITIVE CONTROL SERUM	Jan 14, 1991	Substantially Equivalent	Quidel Corp.
K905176	POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN	Dec 13, 1990	Substantially Equivalent	Quidel Corp.
K904330	TURBO-RAST SPECIFIC IGE ASSAY	Dec 07, 1990	Substantially Equivalent	Ventrex Laboratories, Inc.
K904661	IVT RAST TRACER	Nov 29, 1990	Substantially Equivalent	In Vitro Technologies, Inc.
K903637	ALRGN SET	Nov 21, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K903742	ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE	Oct 15, 1990	Substantially Equivalent	Diagnostic Products Corp.
K902576	ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA	Sep 04, 1990	Substantially Equivalent	Diagnostic Products Corp.
K894190	PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA	Jan 22, 1990	Substantially Equivalent	Pharmacia, Inc.
K897145	3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)	Jan 10, 1990	Substantially Equivalent	3M Company
K896902	ENZYMUN TEST R IGE	Jan 10, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K896852	VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY	Dec 18, 1989	Substantially Equivalent	Ventrex Laboratories, Inc.
K896694	VENTREZYME VAST SPECIFIC IGE ASSAY	Dec 08, 1989	Substantially Equivalent	Ventrex Laboratories, Inc.
K896592	CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY	Dec 04, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K894253	QUIDEL FOOD ALLERGEN SCREEN	Jul 28, 1989	Substantially Equivalent	Quidel Corp.
K893132	PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC	Jun 02, 1989	Substantially Equivalent	Pharmacia, Inc.
K891135	PHADIATOP PAEDIATRIC RIA AND EIA	May 09, 1989	Substantially Equivalent	Pharmacia, Inc.
K892409	QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN	May 04, 1989	Substantially Equivalent	Quidel Corp.
K884501	QUIDEL FOOD ALLERGY SCREEN	Feb 17, 1989	Substantially Equivalent	Quidel Corp.
K885269	ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS	Feb 07, 1989	Substantially Equivalent	Dexall Biomedical Labs, Inc.
K884883	28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)	Jan 23, 1989	Substantially Equivalent	Diagnostic Products Corp.
K884923	MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)	Jan 11, 1989	Substantially Equivalent	Diagnostic Products Corp.
K885065	IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)	Jan 04, 1989	Substantially Equivalent	3M Company
K883537	QM300 CONTROL E	Nov 04, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K884185	CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY	Oct 27, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K883371	MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)	Oct 27, 1988	Substantially Equivalent	3M Company
K883666	QUIDEL ALLERGY SCREEN	Oct 18, 1988	Substantially Equivalent	Quidel Corp.
K883616	SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)	Sep 22, 1988	Substantially Equivalent	Diagnostic Products Corp.
K883273	DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)	Sep 07, 1988	Substantially Equivalent	3M Company
K881899	SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.	Aug 10, 1988	Substantially Equivalent	Diagnostic Products Corp.
K875110	HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC	Jun 14, 1988	Substantially Equivalent	Incstar Corp.
K880899	PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA	May 16, 1988	Substantially Equivalent	Pharmacia, Inc.
K880221	INCSTAR'S PIGWEED ALLERGEN DISC	May 11, 1988	Substantially Equivalent	Incstar Corp.
K880168	INCSTAR'S BIRCH ALLERGEN DISC	May 11, 1988	Substantially Equivalent	Incstar Corp.
K874883	WALNUT ALLERGEN DISC	May 11, 1988	Substantially Equivalent	Incstar Corp.
K874540	MARSH ELDER ALLERGEN DISC	May 11, 1988	Substantially Equivalent	Incstar Corp.
K880567	WHITE ASH ALLERGEN DISC	Apr 21, 1988	Substantially Equivalent	Incstar Corp.
K880415	MESQUITE ALLERGEN DISC	Apr 21, 1988	Substantially Equivalent	Incstar Corp.
K880187	INCSTAR'S DANDELION ALLERGEN DISC	Apr 21, 1988	Substantially Equivalent	Incstar Corp.
K880160	DPC'S ALLERGEN-SPECIFIC IGE SYSTEM	Apr 21, 1988	Substantially Equivalent	Diagnostic Products Corp.
K875244	ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM	Apr 21, 1988	Substantially Equivalent	Diagnostic Products Corp.
K875163	GOLDENROD ALLERGEN DISC	Apr 21, 1988	Substantially Equivalent	Incstar Corp.
K875329	IVT CENTRAL ALLERGY SCREEN	Apr 07, 1988	Substantially Equivalent	In Vitro Technologies, Inc.
K874717	QUIDEL ALLERGY SCREEN	Apr 06, 1988	Substantially Equivalent	Quidel Corp.
K880547	VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY	Mar 25, 1988	Substantially Equivalent	Ventrex Laboratories, Inc.
K875328	IVT WESTERN ALLERGY SCREEN	Mar 23, 1988	Substantially Equivalent	In Vitro Technologies, Inc.
K875168	QUIDEL TOTAL IGE TEST	Mar 18, 1988	Substantially Equivalent	Quidel Corp.
K880003	ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST	Mar 11, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K880001	MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3	Feb 25, 1988	Substantially Equivalent	3M Company
K875125	PROGENE(TM) IGE TEST	Feb 25, 1988	Substantially Equivalent	Progene Corp.
K880002	MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)	Feb 17, 1988	Substantially Equivalent	3M Company
K875274	TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))	Feb 17, 1988	Substantially Equivalent	Incstar Corp.
K874802	FLIPSCREEN QAT	Feb 17, 1988	Substantially Equivalent	Alerchek, Inc.
K875066	ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT	Jan 29, 1988	Substantially Equivalent	Dexall Biomedical Labs, Inc.
K874169	IVT NORTHEAST ALLERGY SCREEN	Jan 11, 1988	Substantially Equivalent	In Vitro Technologies, Inc.
K874168	IVT SOUTHEAST ALLERGY SCREEN	Jan 11, 1988	Substantially Equivalent	In Vitro Technologies, Inc.
K874446	MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)	Dec 30, 1987	Substantially Equivalent	3M Company
K874281	MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT	Dec 18, 1987	Substantially Equivalent	Medix Biotech, Inc.
K874440	LIVE OAK ALLERGEN DISC	Nov 25, 1987	Substantially Equivalent	Incstar Corp.
K874150	JOHNSON GRASS ALLERGEN DISC	Nov 04, 1987	Substantially Equivalent	Incstar Corp.
K874149	FALSE RAGWEED ALLERGEN DISC	Nov 04, 1987	Substantially Equivalent	Incstar Corp.
K873998	TOTAL IGE FAST (TM) TEST PACKAGE	Nov 04, 1987	Substantially Equivalent	3M Company
K873969	GIANT RAGWEED ALLERGEN DISC	Nov 04, 1987	Substantially Equivalent	Incstar Corp.
K873814	IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST	Oct 20, 1987	Substantially Equivalent	Incstar Corp.
K873770	BERMUDA GRASS ALLERGEN DISC	Oct 20, 1987	Substantially Equivalent	Incstar Corp.
K873112	PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC	Oct 20, 1987	Substantially Equivalent	Pharmacia, Inc.
K872946	PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC	Oct 20, 1987	Substantially Equivalent	Pharmacia, Inc.
K873648	BAHIA ALLERGEN DISC	Oct 08, 1987	Substantially Equivalent	Incstar Corp.
K873193	PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS	Oct 08, 1987	Substantially Equivalent	Pharmacia, Inc.
K873676	IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT	Oct 07, 1987	Substantially Equivalent	Incstar Corp.
K873486	RED TOP ALLERGEN DISC	Oct 07, 1987	Substantially Equivalent	Incstar Corp.
K872280	MODIFIED PHADEBAS RAST/PHADEZYM RAST	Oct 07, 1987	Substantially Equivalent	Pharmacia, Inc.
K873406	RRT SHORT RAGWEED TEST KIT	Sep 23, 1987	Substantially Equivalent	Incstar Corp.
K871684	ALTERNARIA TENUIS ALLERGEN DISC	Jul 16, 1987	Substantially Equivalent	Incstar Corp.
K871723	SWEET VERNAL ALLERGEN DISC	Jul 13, 1987	Substantially Equivalent	Incstar Corp.
K871599	DELFIA(TM) HIGE KIT	Jun 12, 1987	Substantially Equivalent	Lkb Instruments, Inc.
K871660	WESTERN RAGWEED ALLERGEN DISC	May 14, 1987	Substantially Equivalent	Incstar Corp.
K870625	IVT SOUTHWEST ALLERGY SCREEN	May 01, 1987	Substantially Equivalent	In Vitro Technologies, Inc.
K871331	VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.	Apr 28, 1987	Substantially Equivalent	Ventrex Laboratories, Inc.
K870966	TOTAL IGE MASTICK	Apr 14, 1987	Substantially Equivalent	Mast Immunosystems
K870009	VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.	Apr 14, 1987	Substantially Equivalent	Ventrex Laboratories, Inc.
K870624	VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY	Mar 24, 1987	Substantially Equivalent	Ventrex Laboratories, Inc.
K864696	ALLERG*ENS ENZYME IMMUNOASSAY KIT	Mar 17, 1987	Substantially Equivalent	Dexall Biomedical Labs, Inc.
K870597	D. FARINAE ALLERGEN DISC	Mar 04, 1987	Substantially Equivalent	Incstar Corp.
K870264	CAT EPITHELIUM ALLERGEN DISC	Feb 13, 1987	Substantially Equivalent	Incstar Corp.
K870153	ALLERGEN SPECIFIC IGG4 CONTROL SERA	Feb 12, 1987	Substantially Equivalent	3M Company
K864104	ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST	Feb 12, 1987	Substantially Equivalent	3M Company
K870152	ALLERGEN SPECIFIC CONTROLS	Feb 06, 1987	Substantially Equivalent	3M Company
K863967	SPECIFIC IGE FAST(TM) TEST II	Dec 22, 1986	Substantially Equivalent	3M Company
K863743	BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT	Dec 15, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K863794	3M IGG4 FAST TEST PACKAGE	Dec 03, 1986	Substantially Equivalent	3M Company
K863394	RAPID SPECIFIC IGE PROCEDURE	Dec 03, 1986	Substantially Equivalent	Allertec, Inc.
K863973	ELM ALLERGEN DISC	Dec 01, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K863844	IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC	Oct 29, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K863036	PHADEBAS RAST/PHADEZYM RAST ALLERTUBE	Oct 03, 1986	Substantially Equivalent	Pharmacia, Inc.
K863123	IMMUNO BIOTECH MUGWART ALLERGEN DISC	Oct 01, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K863355	PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA	Sep 17, 1986	Substantially Equivalent	Pharmacia, Inc.
K862901	VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY	Sep 16, 1986	Substantially Equivalent	Ventrex Laboratories, Inc.
K863098	MEADOW FESCUE ALLERGEN DISC	Sep 15, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862266	MAPLE ALLERGEN DISC	Aug 19, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862939	ORCHARD GRASS ALLERGEN DISC	Aug 15, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862938	JUNE GRASS ALLERGEN DISC	Aug 15, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862265	COTTONWOOD ALLERGEN DISC	Aug 15, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862176	RUSSIAN THISTLE ALLERGEN DISC	Aug 15, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862264	ENGLISH PLAINTAIN ALLERGEN DISC	Jul 03, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862173	PERENNIAL RYE ALLERGEN DISC	Jul 03, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K862175	WHITE OAK ALLERGEN DISC	Jun 20, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K854756	SHORT RAGWEED ALLERGEN DISC	May 15, 1986	Substantially Equivalent	Immuno Nuclear Corp.
K861184	PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS	Apr 25, 1986	Substantially Equivalent	Pharmacia, Inc.
K860027	FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY	Apr 22, 1986	Substantially Equivalent	Alerchek, Inc.
K855053	THABEST-IGE	Apr 22, 1986	Substantially Equivalent	Visual Diagnostics, Inc.
K854865	PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5	Apr 22, 1986	Substantially Equivalent	Pharmacia, Inc.
K854939	PHADEBAS RAST/PHADEZYM RAST ALLERTUBES	Feb 13, 1986	Substantially Equivalent	Pharmacia, Inc.
K853969	PHADEBAS RAST TEST ALLERGEN DISCS	Nov 18, 1985	Substantially Equivalent	Pharmacia, Inc.
K850895	VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY	Oct 16, 1985	Substantially Equivalent	Ventrex Laboratories, Inc.
K853456	PHADEBAS RAST/PHADEZYM RAST ALLERTUBES	Sep 19, 1985	Substantially Equivalent	Pharmacia, Inc.
K852794	ALLERCOAT ALLERGEN DISCS	Sep 19, 1985	Substantially Equivalent	Kallestad Laboratories, Inc.
K852189	PHADEBAS RAST TEST ALLERGEN DISCS	Jul 15, 1985	Substantially Equivalent	Pharmacia, Inc.
K852263	PHADEBAS RAST/PHADEZYM RAST ALLERTUBES	Jun 27, 1985	Substantially Equivalent	Pharmacia, Inc.
K851512	ALLERGENETICS IGE FAST TEST	May 28, 1985	Substantially Equivalent	Allergenetics
K851273	PHADEBAS RAST PHADEZYM RAST ALLERTUBES	May 21, 1985	Substantially Equivalent	Pharmacia, Inc.
K844629	MAST LUMINESCENT ALLERGY SYSTEM	Apr 12, 1985	Substantially Equivalent	Mast Immunosystems
K843694	MAST ALLERGY SYSTEM	Apr 12, 1985	Substantially Equivalent	Mast Immunosystems
K845032	PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS	Mar 21, 1985	Substantially Equivalent	Pharmacia, Inc.
K843302	NEW ALLERG. COATED MICROFILTER WELL STRI	Oct 04, 1984	Substantially Equivalent	Diagnostic Reagent Tech.
K842457	PHADEXACT SERUM, ALLERGEN SPECIFIC IGE	Jul 02, 1984	Substantially Equivalent	Pharmacia, Inc.
K841516	VENTRESCREEN, MULTIPLE ALLERGEN DISCS	May 11, 1984	Substantially Equivalent	Ventrex Laboratories, Inc.
K840670	PHADEBAS RAST PHADEZYM MIX ALLERG	Apr 18, 1984	Substantially Equivalent	Pharmacia, Inc.
K840876	PHADEBAS RAST TEST -ALLERGEN DISCS	Apr 17, 1984	Substantially Equivalent	Pharmacia, Inc.
K834526	MAST INHALANT PROFILE	Apr 04, 1984	Substantially Equivalent	Mast Immunosystems
K840537	RAST ALLERGO SORBENT TEST	Apr 02, 1984	Substantially Equivalent	Pharmacia, Inc.
K833418	CHYMOFAST TEST	Mar 12, 1984	Substantially Equivalent	Allergenetics
K840360	ALLERCOAT MULTISCREEN DISCS	Mar 09, 1984	Substantially Equivalent	Kallestad Laboratories, Inc.
K834598	LIGHT TEST	Feb 10, 1984	Substantially Equivalent	Hemogenetics, Inc.
K833885	MAST INHALANT PROFILE	Jan 04, 1984	Substantially Equivalent	Mast Immunosystems
K832344	POLYSTYRENE MICROTITER PLATE IMMUNO-	Nov 21, 1983	Substantially Equivalent	Diagnostic Reagent Tech.
K832217	VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD	Sep 20, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K831554	NEIN ALLERGEN DISC IN VAST VENTREX TEST	Jun 08, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K831442	PHADEBAS & PHADEZYM RAST ALLERGEN DISCS	Jun 08, 1983	Substantially Equivalent	Pharmacia, Inc.
K831091	NEW ALLERGEN DISC -VAST VENTEX ALLERGY	Apr 27, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K831045	PHADEBAS & PHADEZYM RAST MIXED ALLERG	Apr 27, 1983	Substantially Equivalent	Pharmacia, Inc.
K823592	PHADEBAS & PHADEZYM RAST TEST ALLERG	Mar 24, 1983	Substantially Equivalent	Pharmacia, Inc.
K830155	PHADEBAS & PHADEZYM RAST ALLERGEN DISCS	Mar 10, 1983	Substantially Equivalent	Pharmacia, Inc.
K823593	INHALANT PROFILE-ALLERGEN-SPECIFIC IGE	Feb 25, 1983	Substantially Equivalent	Mast Immunosystems
K830170	RIASSIST RAST DATA REDUCTION/QUALITY	Feb 07, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K830096	PHADEBAS & PHADEZYME RAST ALLERGEN DISC	Jan 28, 1983	Substantially Equivalent	Pharmacia, Inc.
K823470	ALLERCOAT ALLERGEN DISCS	Dec 15, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K822141	PHADEBAS RAST TEST	Aug 03, 1982	Substantially Equivalent	Pharmacia, Inc.
K821451	VAST VENTREX ALLERGY SYSTEMS TESTS	Jun 23, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K820029	KALLESTAD RAST REAGENTS	Apr 06, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K812414	KALLESTAD 125I ANTISERUM TO HUMAN IGE	Sep 14, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.
K810462	PHADEZYM RAST TEST	Mar 11, 1981	Substantially Equivalent	Pharmacia, Inc.
K802556	PHADEBAS RAST TEST	Dec 02, 1980	Substantially Equivalent	Pharmacia, Inc.
K771578	PHADEBAS RAST PENICLLOYL G/V TEST	Sep 02, 1977	Substantially Equivalent	Pharmacia, Inc.