Product Code: JTO FDA class 1 21 CFR 866.2660

Discs, Strips And Reagents, Microorganism Differentiation

Microbiology

Discs, Strips and Reagents, Microorganism Differentiation are microbiological reagent products used to perform biochemical differentiation tests that distinguish between closely related microbial species or genera based on enzymatic or metabolic reactions. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JTO, regulated under 21 CFR 866.2660, and falls within the Microbiology medical specialty.

View on FDA

510(k)s

244

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: JTO
Device Class: FDA class 1
Regulation Number: 866.2660
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

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 244 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K050352	IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT	Sep 01, 2005	Substantially Equivalent	Ameritek Research, LLC
K970832	PYR SWAB	Apr 24, 1997	Substantially Equivalent	Remel, Inc.
K970834	GRAM SWAB	Apr 17, 1997	Substantially Equivalent	Remel, Inc.
K970833	INDOLE SWAB	Apr 02, 1997	Substantially Equivalent	Remel, Inc.
K970009	LYFO(TM) DIFFERENTIAL DISK-BACITRACIN	Feb 06, 1997	Substantially Equivalent	Microbiologics, Inc.
K962966	IDS RAPID CB PLUS SYSTEM	Oct 08, 1996	Substantially Equivalent	Innovative Diagnostic Systems, Inc.
K961191	COLISCREEN	Jun 17, 1996	Substantially Equivalent	Hardy Diagnostics
K960996	M. CAT BUTYRATE DISK	Apr 18, 1996	Substantially Equivalent	Hardy Diagnostics
K955826	GIBSON ID-M. CAT.	Feb 29, 1996	Substantially Equivalent	Gibson Laboratories, Inc.
K954783	DRYSLIDE CARTARRHALIS	Feb 06, 1996	Substantially Equivalent	Difco Laboratories, Inc.
K954812	LYFO(TM) DIFFERIENTAL DISK-PYR	Dec 20, 1995	Substantially Equivalent	Microbiologics, Inc.
K953247	GIBSON ID A.E. TEST	Nov 20, 1995	Substantially Equivalent	Gibson Laboratories, Inc.
K951889	LYFO(TM) DIFFERENTIAL DISK	Aug 24, 1995	Substantially Equivalent	Microbiologics, Inc.
K950346	B-L RED(TM) DISCS	May 05, 1995	Substantially Equivalent	Oxis Intl., Inc.
K945883	LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN	Apr 24, 1995	Substantially Equivalent	Microbiologics, Inc.
K945882	LYFO(TM) DIFFERENTIAL DISK-BILE	Apr 24, 1995	Substantially Equivalent	Microbiologics, Inc.
K945881	LYFO(TM) DIFFERENTIAL DISK-STERILE DISK	Apr 24, 1995	Substantially Equivalent	Microbiologics, Inc.
K945880	LYFO(TM) DIFFERENTIAL DISK-SPS	Apr 24, 1995	Substantially Equivalent	Microbiologics, Inc.
K934130	SWABZYME OXIDASE	Sep 14, 1994	Substantially Equivalent	E-Y Laboratories, Inc.
K940162	GONOCHEK II REAGENT TUBES	Sep 09, 1994	Substantially Equivalent	E-Y Laboratories, Inc.
K940161	B-LACTAMASE REAGENT TUBES	Sep 09, 1994	Substantially Equivalent	E-Y Laboratories, Inc.
K934125	GONOCHEK-II, MODIFICATION	Sep 09, 1994	Substantially Equivalent	E-Y Laboratories, Inc.
K940124	EY-20 REAGENT TUBES	Aug 26, 1994	Substantially Equivalent	E-Y Laboratories, Inc.
K940020	STREP-A-CHEK(TM) REAGENT STRIPS	Aug 26, 1994	Substantially Equivalent	E-Y Laboratories, Inc.
K934129	STREP-A-CHEK	Aug 26, 1994	Substantially Equivalent	E-Y Laboratories, Inc.
K941111	STREP-SURE A/E	Aug 02, 1994	Substantially Equivalent	Clinical Standards Laboratories, Inc.
K941016	DISPENS-O-DISC(TM) NITROCEFIN	Jun 30, 1994	Substantially Equivalent	Difco Laboratories, Inc.
K936021	BACTICARD STREP	May 20, 1994	Substantially Equivalent	Remel Co.
K936034	SERIM PYLORITEK REAGENT STRIPS	Apr 21, 1994	Substantially Equivalent	Serim Research Corp.
K934986	BACTICARD E. COLI	Feb 23, 1994	Substantially Equivalent	Remel Co.
K931865	PYR TEST KIT	Dec 15, 1993	Substantially Equivalent	Hardy Diagnostics
K932752	VISI-SPOT	Nov 05, 1993	Substantially Equivalent	J.S. Medical Assoc.
K933514	BACTICARD STREP	Oct 28, 1993	Substantially Equivalent	Remel Co.
K931862	NINHYDRIN REAGENT	Jun 15, 1993	Substantially Equivalent	Hardy Diagnostics
K931414	CATALASE REAGENT	May 12, 1993	Substantially Equivalent	Hardy Diagnostics
K930693	OXYSTRIP	May 12, 1993	Substantially Equivalent	Hardy Diagnostics
K931413	FERRIC CHLORID REAGENT, 10%	May 11, 1993	Substantially Equivalent	Hardy Diagnostics
K930878	BACTIDROP(TM) MUCAP	May 11, 1993	Substantially Equivalent	Remel Co.
K930720	VOGUES-PROSKAUER REAGENT A & B	Apr 23, 1993	Substantially Equivalent	Hardy Diagnostics
K930718	INDOLE SPOT & INDOLE KOVACS REAGENT	Apr 23, 1993	Substantially Equivalent	Hardy Diagnostics
K930717	NITRATE REAGENTS A, B AND C	Apr 23, 1993	Substantially Equivalent	Hardy Diagnostics
K926256	BBL NINHYDRIN REAGENT DROPPERS	Jan 26, 1993	Substantially Equivalent	Becton Dickinson Microbiology Systems
K926255	BBL NITRATE A, B REAGENT DROPPERS	Jan 26, 1993	Substantially Equivalent	Becton Dickinson Microbiology Systems
K926254	BBL PYR REAGENT DROPPERS	Jan 26, 1993	Substantially Equivalent	Becton Dickinson Microbiology Systems
K925747	DRYSLIDE(TM) INDOLE	Jan 15, 1993	Substantially Equivalent	Difco Laboratories, Inc.
K923700	INDOXYL ACETATE DISK	Oct 05, 1992	Substantially Equivalent	Remel Co.
K923827	LAP DISK	Sep 28, 1992	Substantially Equivalent	Remel Co.
K921583	DRYSLIDE(TM), PYR	Jun 19, 1992	Substantially Equivalent	Difco Laboratories, Inc.
K920973	BACTIDROP INDOLE (ERLICH'S)	Jun 19, 1992	Substantially Equivalent	Remel Co.
K920972	BACTIDROP PYR	May 22, 1992	Substantially Equivalent	Remel Co.
K920971	BACTIDROP NINHYDRIN	May 22, 1992	Substantially Equivalent	Remel Co.
K920257	NIACIN CONTROL DISKS	Apr 22, 1992	Substantially Equivalent	Remel Co.
K913008	BACTIDROP(TM) OXIDASE	Sep 23, 1991	Substantially Equivalent	Remel Co.
K913007	BACTIDROP(TM) VOGES-PROSKAUER B	Sep 23, 1991	Substantially Equivalent	Remel Co.
K913006	BACTIDROP(TM) DOBELL & O'CONNOR IODINE	Sep 23, 1991	Substantially Equivalent	Remel Co.
K913003	BACTIDROP(TM) VOGES-PROSKAUER A	Sep 23, 1991	Substantially Equivalent	Remel Co.
K913002	BACTIDROP(TM) FERRIC CHLORIDE (10%)	Sep 23, 1991	Substantially Equivalent	Remel Co.
K913011	BACTIDROP(TM) NITRATE A	Sep 19, 1991	Substantially Equivalent	Remel Co.
K913010	BACTIDROP (TM) NITRATE B	Sep 19, 1991	Substantially Equivalent	Remel Co.
K913009	BACTIDROP(TM) INDOLE (KOVACS)	Sep 18, 1991	Substantially Equivalent	Remel Co.
K913004	BACTIDROP(TM) SPOT INDOLE	Sep 18, 1991	Substantially Equivalent	Remel Co.
K913001	BACTIDROP(TM) DESOXYCHOLATE (10%)	Sep 18, 1991	Substantially Equivalent	Remel Co.
K912480	BBL(R) DMACA INDOLE REAGENT DROPPERS	Aug 23, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K905472	LAP DISCS	Feb 27, 1991	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K905666	M. CAT. BUTYRATE DISC	Feb 26, 1991	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K905163	NITRATE DISK	Feb 20, 1991	Substantially Equivalent	Remel Co.
K905151	VANCOMYCIN DISK-5 MCG	Jan 25, 1991	Substantially Equivalent	Remel Co.
K902595	CATARRHALIS TEST STRIP	Oct 02, 1990	Substantially Equivalent	Remel Co.
K902640	DMAC INDOLE REAGENT	Jul 16, 1990	Substantially Equivalent	Api Analytab Products
K901784	DRYSLIDE, BETA-LACTAMASE	Jun 20, 1990	Substantially Equivalent	Difco Laboratories, Inc.
K902037	PATHODX PYR KIT	Jun 01, 1990	Substantially Equivalent	Diagnostic Products Corp.
K901390	DMAC INDOLE REAGENT	Apr 16, 1990	Substantially Equivalent	Analytical Products, Inc.
K896398	DIFCO OXIDASE DRYSLIDE	Dec 18, 1989	Substantially Equivalent	Difco Laboratories, Inc.
K894221	ROSCO PYRR	Sep 28, 1989	Substantially Equivalent	Pro-Lab, Inc.
K890625	JAMES REAGENT	Feb 17, 1989	Substantially Equivalent	Dms Products, Inc.
K882636	ALN DISCS	Feb 16, 1989	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K882630	PRO DISCS	Feb 16, 1989	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K880694	B. CAT CONFIRM	Jun 16, 1988	Substantially Equivalent	Scott Laboratories, Inc.
K880950	PYR/ESCULIN DISK	Apr 01, 1988	Substantially Equivalent	Remel Co.
K874933	MUG-INDOLE DISC	Jan 05, 1988	Substantially Equivalent	Scott Laboratories, Inc.
K873509	IDENTICULT-BL	Oct 15, 1987	Substantially Equivalent	Scott Laboratories, Inc.
K873034	CONTROLCHEK II(TM)	Aug 19, 1987	Substantially Equivalent	Petra Biomedical Products, Inc.
K871907	LD PRESUMPTO QUAD	May 28, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K871445	CONTROLCHEK(TM)	Apr 29, 1987	Substantially Equivalent	Petra Biomedical Products, Inc.
K870561	CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION	Apr 21, 1987	Substantially Equivalent	Diversified Diagnostic Industries
K870422	GEN-PROBE BETA-LACTAMASE TEST KIT	Apr 21, 1987	Substantially Equivalent	Gen-Probe, Inc.
K870410	CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS	Apr 21, 1987	Substantially Equivalent	Diversified Diagnostic Industries
K870409	CHROMAGEN TEST FOR GROUP A STREP	Apr 15, 1987	Substantially Equivalent	Diversified Diagnostic Industries
K870717	SPOTTEST MICRODASE	Apr 03, 1987	Substantially Equivalent	Difco Laboratories, Inc.
K870716	SPOTTEST 10% SODIUM DESOXYCHOLATE	Apr 03, 1987	Substantially Equivalent	Difco Laboratories, Inc.
K864244	GARNERELLA VAGINALIS IDENTIFICATION KIT	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K870449	SPOTTEST PYR REAGENT	Feb 26, 1987	Substantially Equivalent	Difco Laboratories, Inc.
K863601	ONPG SOLUTION	Sep 30, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863216	NEIS NZY	Sep 15, 1986	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K862570	DISPENS-O-DISC DIFFERENTIATION DISKS PYR	Jul 17, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K861889	D'ALA RAPID TEST	Jun 03, 1986	Substantially Equivalent	Pro-Lab, Inc.
K861888	HIPPURATE HYDROLYSIS TEST	Jun 03, 1986	Substantially Equivalent	Pro-Lab, Inc.
K861058	SENSITITRE AUTO ID PLATE, AP70	May 20, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K861259	MACCONKEY W/MUG	Apr 11, 1986	Substantially Equivalent	Remel Co.
K860565	DIFFERENTIATION DISKS KANAMYCIN 1000 MCG	Mar 11, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860564	DIFFERENTIATION DISKS ERYTHROMYCIN 60 MCG	Mar 11, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860563	DIFFERENTIATION DISKS VANCOMYCIN 5 MCG	Mar 11, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860562	DIFFERENTIATION DISKS COLISTIN 10 MCG	Mar 11, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860561	DIFFERENTIATION DISKS PENICILLIN G 2 UNITS	Mar 11, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860560	DIFFERENTIATION DISKS RIFAMPIN 15 MCG	Mar 11, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860156	NEISSERIASTAT	Mar 11, 1986	Substantially Equivalent	Richardson Scientific, Inc.
K860396	BIOTIS NUTRIENT GELATIN	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860301	RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE	Feb 06, 1986	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K860302	PYR DISCS	Feb 05, 1986	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K860091	BIO SPEC GRAMAFLUOR TEST KIT	Jan 21, 1986	Substantially Equivalent	Bio Spec, Inc.
K854448	AUTOSCAN W/A SYSTEM	Nov 26, 1985	Substantially Equivalent	American Micro Scan
K852889	GENERAL DIAGNOSTICS RAPID E. COLI TEST	Jul 23, 1985	Substantially Equivalent	Warner-Lambert Co.
K852886	MUG DISK	Jul 23, 1985	Substantially Equivalent	Remel Co.
K852832	IDENTICULT-NEISSERIA	Jul 19, 1985	Substantially Equivalent	Scott Laboratories, Inc.
K852666	IDENTICULT-AE	Jul 15, 1985	Substantially Equivalent	Scott Laboratories, Inc.
K851184	SPOTTEST INDIA INK	Apr 01, 1985	Substantially Equivalent	Difco Laboratories, Inc.
K844887	IDENTIFICATION STICKS OXIDASE	Feb 25, 1985	Substantially Equivalent	Oxoid U.S.A., Inc.
K844383	KANAMYCIN 1000 MCG DIFFERENTIAL DISK	Jan 04, 1985	Substantially Equivalent	Anaerobe Systems
K844382	VANCOMYCIN 5MCG DIFFERENTIAL DISK	Jan 04, 1985	Substantially Equivalent	Anaerobe Systems
K844381	COLISTIN 10 MCG. DIFFERENTIAL DISK	Jan 04, 1985	Substantially Equivalent	Anaerobe Systems
K844380	BILE DIFFERENTIAL DISK	Jan 04, 1985	Substantially Equivalent	Anaerobe Systems
K844276	E-COLI-CHEK TUBE	Dec 13, 1984	Substantially Equivalent	E-Y Laboratories, Inc.
K844020	PYRIDOXAL DISC	Dec 13, 1984	Substantially Equivalent	Remel Co.
K844086	POS COMBO PANEL	Nov 13, 1984	Substantially Equivalent	American Micro Scan
K844019	STREP ID TRIPLATE	Oct 31, 1984	Substantially Equivalent	Remel Co.
K843987	PYR BROTH	Oct 30, 1984	Substantially Equivalent	Remel Co.
K843521	DIFFERENTIATION DISKS NITRATE	Oct 02, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K843316	INDOLE SPOT TEST KIT 270-25	Sep 11, 1984	Substantially Equivalent	Applied Polytechnology, Inc.
K842828	STREPTEX ZL01	Aug 15, 1984	Substantially Equivalent	Wellcome Diagnostics
K842587	GNC PLUS	Jul 20, 1984	Substantially Equivalent	Vitek Systems, Inc.
K842086	SPOTTEST LACTOPHENOL COTTON BLUE STAIN	Jul 03, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K841460	RIM GARDNERELLA VAGINALIS KIT	May 02, 1984	Substantially Equivalent	Austin Biological Laboratories
K841453	DIFFERENTIATION DISKS SPECTINOMYCIN	May 02, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K841329	RIM ONPG KIT	May 02, 1984	Substantially Equivalent	Austin Biological Laboratories
K841479	BIO SPEC STREP-A-FLUOR TEST KIT	Apr 25, 1984	Substantially Equivalent	Bio Spec, Inc.
K841508	RIM 6.5% NACL	Apr 20, 1984	Substantially Equivalent	Austin Biological Laboratories
K841277	RIM-HIPPURATE	Apr 20, 1984	Substantially Equivalent	Austin Biological Laboratories
K841270	RIM - NITRATE TEST	Apr 20, 1984	Substantially Equivalent	Austin Biological Laboratories
K841262	RIM-BILE ESCULIN TEST	Apr 20, 1984	Substantially Equivalent	Austin Biological Laboratories
K840708	COLISTIN DISC	Apr 13, 1984	Substantially Equivalent	Remel Co.
K840686	2U PENICILLIN DISC	Apr 13, 1984	Substantially Equivalent	Remel Co.
K840614	RIFAMPIN DISC	Apr 13, 1984	Substantially Equivalent	Remel Co.
K840810	SWABZYME-OXIDASE	Apr 04, 1984	Substantially Equivalent	E-Y Laboratories, Inc.
K840896	DIFFERENTIATION DISKS ALA	Mar 23, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840884	STREP-A-CHEK TUBE	Mar 23, 1984	Substantially Equivalent	E-Y Laboratories, Inc.
K840819	MICRODASE	Mar 23, 1984	Substantially Equivalent	Remel Co.
K840804	DIFFERENTIATION DISKS SPS	Mar 23, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840508	NEISSERIA MENINGITIDIS GR. C	Mar 23, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K834389	AMS GRAM-POSITIVE IDENT. CARD	Mar 09, 1984	Substantially Equivalent	Vitek Systems, Inc.
K834269	AMS GRAM-NEGATIVE IDENT. CARD	Mar 09, 1984	Substantially Equivalent	Vitek Systems, Inc.
K840584	SPOTTEST ACRIDINE ORANGE STAIN	Mar 02, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840483	NOVOBIOCIN DISC	Mar 02, 1984	Substantially Equivalent	Remel Co.
K840031	MICROBIAL DIFFERENTIATION	Mar 02, 1984	Substantially Equivalent	Anaerobe Systems
K840030	REAGENTS	Mar 02, 1984	Substantially Equivalent	Anaerobe Systems
K840029	STRIPS	Mar 02, 1984	Substantially Equivalent	Anaerobe Systems
K840028	DISCS	Mar 02, 1984	Substantially Equivalent	Anaerobe Systems
K840583	SPOTTEST VOGES-PROSKAUER REAGENT B	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840582	SPOTTEST FERRIC CHLORIDE REAGENT	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840581	SPOTTEST NITRATE REAGENT C	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840580	SPOTTEST NITRATE REAGENT B	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840579	SPOTTEST NITRATE REAGENT A	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840578	SPOTTEST VOGES-PROSKAUER REAGENT A	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840577	SPOTTEST KOVACS' INDOLE REAGENT	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840576	SPOTTEST DMACA INDOLE REAGENT	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840575	SPOTTEST OXIDASE REAGENT	Feb 27, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840252	RIM GRAM REACTION SWAB	Feb 27, 1984	Substantially Equivalent	Austin Biological Laboratories
K834581	DIFFERENTIATION DISKS HIPPURATE	Feb 13, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K833654	IDS RAPID STR SYSTEM	Feb 13, 1984	Substantially Equivalent	Innovative Diagnostic Systems, Inc.
K834029	BIO-UREA	Dec 30, 1983	Substantially Equivalent	Remel Co.
K834028	BIO-ORNITHINE	Dec 30, 1983	Substantially Equivalent	Remel Co.
K834022	PVP IODINE	Dec 30, 1983	Substantially Equivalent	Remel Co.
K833963	HAEMOPHILUS IDENTIFICATION TEST KIT	Dec 30, 1983	Substantially Equivalent	Remel Co.
K833407	SELECTO-DISC NOVOBIOCIN 5UG	Dec 30, 1983	Substantially Equivalent	Lab Ability, Inc.
K833901	BACTROL GRAM SLIDE	Dec 08, 1983	Substantially Equivalent	Difco Laboratories, Inc.
K832587	RIME COLI KIT	Oct 04, 1983	Substantially Equivalent	Austin Biological Laboratories
K832436	SELECTRO-DISC	Sep 26, 1983	Substantially Equivalent	Lab Ability, Inc.
K832307	ONPG DISCS	Aug 26, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K832306	BILE AESCULIN DISCS	Aug 24, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K832305	SPS DISCS	Aug 24, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K830756	GONOCHEK PANEL	Aug 12, 1983	Substantially Equivalent	E-Y Laboratories, Inc.
K831674	RIM-CAMP TEST	Jun 30, 1983	Substantially Equivalent	Austin Biological Laboratories
K831673	OXY-SWAB	Jun 30, 1983	Substantially Equivalent	Austin Biological Laboratories
K831654	RIM BETA LACTAMASE TEST	Jun 22, 1983	Substantially Equivalent	Austin Biological Laboratories
K830968	RAPID IDENTIFI-METHOD NEISSERIA KIT	Jun 16, 1983	Substantially Equivalent	Austin Biological Laboratories
K831187	TRP	May 09, 1983	Substantially Equivalent	Dms Laboratories
K830939	THYMINE/THYMIDINE DISCS DDG	Apr 13, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K830323	LYSOSTAPHIN REAGENT SET	Feb 28, 1983	Substantially Equivalent	Remel Co.
K830099	MS-2 BACTERIAL IDENTI. SYS	Feb 15, 1983	Substantially Equivalent	Abbott Laboratories
K823718	SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP	Feb 07, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K823738	GRAM NEGATIVE BACTERIAL IDENTIF- PANELS	Jan 07, 1983	Substantially Equivalent	Micro-Media Systems, Inc.
K823198	RAPID PRESUMPTIVE IDENT. GPA STREP	Nov 16, 1982	Substantially Equivalent	Microchemical Specialities, Co.
K822946	BACTEC NAP TB DIFFERENTIATION TEST	Nov 12, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K822930	CSM CHROMOGENIC B-LACTAMASE DISC	Nov 01, 1982	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K821992	ALPHA-TOXIN DISCS	Oct 18, 1982	Substantially Equivalent	Microchemical Specialities, Co.
K821907	NEIDENT*	Jul 22, 1982	Substantially Equivalent	Analytical Products, Inc.
K821040	RAPID SST	May 03, 1982	Substantially Equivalent	Mds Laboratories, Inc.
K820264	AMS GRAM-POSITIVE IDENTIFICATION CARD	May 03, 1982	Substantially Equivalent	Vitek Systems, Inc.
K813613	RAPID CH	Feb 22, 1982	Substantially Equivalent	Dms Laboratories
K813612	RAPID ZYME	Feb 22, 1982	Substantially Equivalent	Dms Laboratories
K820213	SALINE SOLUTION	Feb 12, 1982	Substantially Equivalent	Dms Laboratories
K820212	OXI	Feb 12, 1982	Substantially Equivalent	Dms Laboratories
K820211	NINHYDRIN	Feb 12, 1982	Substantially Equivalent	Dms Laboratories
K820210	IND	Feb 12, 1982	Substantially Equivalent	Dms Laboratories
K820209	ZYME B	Feb 12, 1982	Substantially Equivalent	Dms Laboratories
K820207	NIT 2	Feb 05, 1982	Substantially Equivalent	Dms Laboratories
K820206	NIT 1	Feb 05, 1982	Substantially Equivalent	Dms Laboratories
K820205	VP 2	Feb 05, 1982	Substantially Equivalent	Dms Laboratories
K820204	VP I	Feb 05, 1982	Substantially Equivalent	Dms Laboratories
K813610	RAPID STREP	Feb 04, 1982	Substantially Equivalent	Dms Laboratories
K813509	METRONIDAZOLE DIAGNOSTIC DISCS	Dec 31, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K813442	CEFINASE TM DISCS	Dec 29, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K813031	MS-2 BACTERIAL IDENTIFICATION SYS	Dec 17, 1981	Substantially Equivalent	Abbott Laboratories
K812877	PENASE	Oct 26, 1981	Substantially Equivalent	Analytab Products, Inc.
K812862	API GERM TUBE	Oct 26, 1981	Substantially Equivalent	Analytab Products, Inc.
K812859	IDS PORPHYRIN REAGENT	Oct 26, 1981	Substantially Equivalent	Innovative Diagnostic Systems, Inc.
K812458	PADAC	Sep 23, 1981	Substantially Equivalent	Calbiochem-Behring Corp.
K812084	SPS DISK	Aug 13, 1981	Substantially Equivalent	Remel Co.
K812083	BILE DISK	Aug 13, 1981	Substantially Equivalent	Remel Co.
K812082	KANAMYCIN DISK	Aug 13, 1981	Substantially Equivalent	Remel Co.
K812047	IDS BETA-LACTAMASE DISC	Aug 07, 1981	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K811998	STAPH-IDENT	Jul 28, 1981	Substantially Equivalent	Analytical Products, Inc.
K811854	GALACTOSID-ASE TUBES	Jul 16, 1981	Substantially Equivalent	Microchemical Specialities, Co.
K811853	PHOLPHORYL-ASE TUBES	Jul 16, 1981	Substantially Equivalent	Microchemical Specialities, Co.
K810541	BETA LYSIN DISK	Mar 17, 1981	Substantially Equivalent	Remel Co.
K802509	G.R.A.M. SLIDE	Nov 12, 1980	Substantially Equivalent	Sterilization Technical Services, Inc.
K802502	X & V FACTOR DISCS	Nov 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K802501	V FACTOR DISCS	Nov 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K802500	X-FACTOR DISCS	Nov 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K802497	BACTIRACIN DIAGNOSTIC DISC	Nov 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K802496	OPTOCHIN DIAGNOSTIC DISC	Nov 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K802566	BETA LACTAMASE REAGENT DISK	Oct 31, 1980	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K801951	API-CTS STREPTOCOCCUS	Sep 26, 1980	Substantially Equivalent	Analytical Products, Inc.
K802127	BACITRACIN DIFFERENTIATION DISC	Sep 16, 1980	Substantially Equivalent	Biomedia, Inc.
K801916	ORNITH-ASE TUBES	Aug 20, 1980	Substantially Equivalent	Microchemical Specialities, Co.
K801915	ENZYME-ASE I TUBES	Aug 20, 1980	Substantially Equivalent	Microchemical Specialities, Co.
K801493	ALA SWAB	Aug 13, 1980	Substantially Equivalent	Remel Co.
K801492	PORPHYRIN (ALA) DISK	Aug 13, 1980	Substantially Equivalent	Remel Co.
K800816	HIPPUR-ASE TUBES	Jul 08, 1980	Substantially Equivalent	Microchemical Specialities, Co.
K800579	BETA-ASE TUBES	Apr 08, 1980	Substantially Equivalent	Microchemical Specialities, Co.
K782086	AM-PEN SCREEN	Feb 01, 1979	Substantially Equivalent	Pfizer, Inc.
K790038	DISK, BETA-LACTAM	Jan 26, 1979	Substantially Equivalent	Remel Co.
K781567	API ZYM	Dec 20, 1978	Substantially Equivalent	Analytical Products, Inc.
K770926	SUSPENSION SALINE, API 20E	Jun 17, 1977	Substantially Equivalent	Analytical Products, Inc.
K761209	TAXO DISCS FOR DIFF. OF ANAEROBES	Dec 09, 1976	Substantially Equivalent	Bioquest