Product Code: JJQ FDA class 1 21 CFR 862.2300

Colorimeter, Photometer, Spectrophotometer For Clinical Use

Clinical Chemistry

This device is a colorimeter, photometer, or spectrophotometer intended for clinical laboratory use to measure the absorbance or transmittance of light by patient specimens or reaction products, enabling quantitative determination of biochemical analytes based on color intensity. It is classified as FDA Class 1 and is subject only to general controls with no premarket notification required. The product code is JJQ, regulated under 21 CFR 862.2300, and assigned to the Clinical Chemistry medical specialty.

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510(k)s

258

FEI Numbers

Registration Numbers

Unique Applicants

125

Years Active

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Basic Information

Product Code: JJQ
Device Class: FDA class 1
Regulation Number: 862.2300
Medical Specialty: Clinical Chemistry
Review Panel: CH
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 258 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K013371	UBIT-IR300 INFRARED SPECTROMETRY SYSTEM	Dec 21, 2001	Substantially Equivalent	Otsuka Pharmaceutical Co., Ltd.
K980120	DIGENE DML 2000 MICROPLATE LUMINOMETER	Feb 06, 1998	Substantially Equivalent	Digene Corp.
K973938	ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER	Feb 04, 1998	Substantially Equivalent	Sfri, Inc.
K974762	STAT TRACKS	Jan 28, 1998	Substantially Equivalent	Awareness Technology, Inc.
K962113	ANTHOS PHACTS VERSION MICROPLATE READER	Nov 05, 1996	Substantially Equivalent	Columbia Bioscience, Inc.
K961183	CBI 7520 READER	Aug 02, 1996	Substantially Equivalent	Columbia Bioscience, Inc.
K962166	ORIGEN ANALYZER	Jul 31, 1996	Substantially Equivalent	Igen, Inc.
K955077	ANTHOS 2010 READER	Dec 04, 1995	Substantially Equivalent	Anthos Labtec, Inc.
K953710	ELX808 AUTOMATED MICROPLATE READERS	Oct 25, 1995	Substantially Equivalent	Bio-Tek Instruments, Inc.
K953572	ELX800UV	Oct 19, 1995	Substantially Equivalent	Bio-Tek Instruments, Inc.
K953005	BILI-METER	Sep 28, 1995	Substantially Equivalent	Olympic Medical Corp.
K950029	5STRATEC SL 300 LIA-MAT	Aug 02, 1995	Substantially Equivalent	Nichols Institute Diagnostics
K940486	DIGENE DCR-1 LUMINOMETER	Apr 18, 1995	Substantially Equivalent	Digene Diagnostics, Inc.
K942361	WHITSOFT	Apr 04, 1995	Substantially Equivalent	Biowhittaker Molecular Applications, Inc.
K942250	BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER	Apr 04, 1995	Substantially Equivalent	Biowhittaker Molecular Applications, Inc.
K942245	BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE	Apr 03, 1995	Substantially Equivalent	Biowhittaker Molecular Applications, Inc.
K950104	ELX800 AND EL800 AUTOMATED MICROPLATE READERS	Mar 21, 1995	Substantially Equivalent	Bio-Tek Instruments, Inc.
K942923	CERES 900C & CERES UV900C	Feb 06, 1995	Substantially Equivalent	Bio-Tek Instruments, Inc.
K943454	PLATO 3300/1300	Jan 09, 1995	Substantially Equivalent	Rosys, Inc.
K935983	MICROREADER 4	Dec 09, 1994	Substantially Equivalent	Hyperion, Inc.
K943595	SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM	Nov 28, 1994	Substantially Equivalent	Instrumentation Laboratory CO
K941050	DUPONT ACA STAR	Nov 10, 1994	Substantially Equivalent	Dupont Medical Products
K943701	MRX MICROPLATE READER	Oct 20, 1994	Substantially Equivalent	Dynatech Laboratories, Inc.
K932778	BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER	Nov 17, 1993	Substantially Equivalent	Boehringer Mannheim Corp.
K932467	ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM	Nov 05, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K921536	ACCULYTE CHEMILUMINESCENCE ANALYZER	Oct 12, 1993	Substantially Equivalent	Laboratory Technologies, Inc.
K931907	ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III	Sep 29, 1993	Substantially Equivalent	Anthos Labtec Instruments
K925625	OMNI	Aug 19, 1993	Substantially Equivalent	Bio-Tek Instruments, Inc.
K925935	OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER	Apr 22, 1993	Substantially Equivalent	Olympus Corp.
K923844	LYRIS 100/120 LABORATORY INFORMATION SYSTEM	Dec 11, 1992	Substantially Equivalent	Biovation, Inc.
K925203	TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1	Nov 25, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K923158	LUMICO ANALYZER SA-300	Nov 17, 1992	Substantially Equivalent	Maruzen Petrochemical Co., Ltd.
K922976	LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT	Nov 16, 1992	Substantially Equivalent	Eg&G Berthold Analytical Instruments, Inc.
K922329	BERTHOLD LB 954	Nov 16, 1992	Substantially Equivalent	Eg&G Berthold Analytical Instruments, Inc.
K923456	MICROLITE MICROTITER PLATE LUMINOMETER ML3000	Oct 13, 1992	Substantially Equivalent	Dynatech Laboratories, Inc.
K922081	LABOTECH AUTOMATED MICROTITER ANALYZER	Sep 02, 1992	Substantially Equivalent	Innovative Medical Systems, Inc.
K921180	COBAS CORE IMMUNOCHEMISTRY SYSTEM	Jul 28, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K915896	MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI	May 04, 1992	Substantially Equivalent	Dynatech Laboratories, Inc.
K915690	SLT 340 ATTC	Apr 22, 1992	Substantially Equivalent	Slt Labinstruments, Inc.
K915689	SLT SPECTRA	Apr 22, 1992	Substantially Equivalent	Slt Labinstruments, Inc.
K920914	MP/S SINGLE WAVELENGTH MINI PHOTOMETER	Mar 23, 1992	Substantially Equivalent	Artel, Inc.
K915113	ENCORE	Mar 18, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K915680	AMERLITE PROCESSING CENTER	Mar 11, 1992	Substantially Equivalent	Eastman Kodak Company
K914906	AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT	Nov 27, 1991	Substantially Equivalent	Bio-Tek Instruments, Inc.
K913590	MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER	Oct 25, 1991	Substantially Equivalent	Dynatech Laboratories, Inc.
K914202	BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE	Oct 11, 1991	Substantially Equivalent	Baxter Diagnostics, Inc.
K913840	MICROTAK PLUS	Sep 30, 1991	Substantially Equivalent	Syva Co.
K913295	OPUS(R) PLUS ANALYZER	Sep 11, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K912368	IMX SELECT ANALYZER	Sep 11, 1991	Substantially Equivalent	Abbott Laboratories
K910806	METROLAB MODEL 1500	Aug 30, 1991	Substantially Equivalent	Laboratorio Rodriguez Corswant S.R.L.
K912959	MICROTRAK MANAGER	Jul 26, 1991	Substantially Equivalent	Syva Co.
K912413	CHEM-LINK DATA BASE MANAGER	Jul 01, 1991	Substantially Equivalent	Technicon Instruments Corp.
K911045	OBA(TM) READER	Jun 24, 1991	Substantially Equivalent	Adeza Biomedical
K911438	TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE	May 23, 1991	Substantially Equivalent	Bio-Tek Instruments, Inc.
K904783	DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER	Apr 18, 1991	Substantially Equivalent	Industrial Chemical Measurement
K910740	SLT MICROPLATE WASHER	Mar 27, 1991	Substantially Equivalent	Tecan U.S., Ltd.
K910302	ECLIPSE ICA ANALYZER	Feb 22, 1991	Substantially Equivalent	Biotope, Inc.
K904567	DYNATECH MR4000 MICROPLATE READER	Jan 28, 1991	Substantially Equivalent	Dynatech Corp.
K905762	GEN-PROBE LUMINOMETER-LEADER 450	Jan 23, 1991	Substantially Equivalent	Gen-Probe, Inc.
K905215	IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER	Jan 11, 1991	Substantially Equivalent	Cirrus Diagnostics, Inc.
K903911	GEN-PROBE PAL LUMINOMETER	Oct 04, 1990	Substantially Equivalent	Gen-Probe, Inc.
K903934	GEN-PROBE LUMINOMETER-LEADER 50	Sep 27, 1990	Substantially Equivalent	Gen-Probe, Inc.
K903164	EURAMARK 610 PHOTOMETER	Aug 09, 1990	Substantially Equivalent	Euro-American Marketing Group, Inc.
K902776	SPECTROPHOTOMETER (MICROASSAY PLATE READERS)	Jul 31, 1990	Substantially Equivalent	Slt Labinstruments, Inc.
K901829	BEHRING CHROMOTIMER	Jul 24, 1990	Substantially Equivalent	Behring Diagnostics, Inc.
K901695	QUICK CHEM II	May 24, 1990	Substantially Equivalent	Seradyn, Inc.
K901965	MPR-4A - MICRO-PLATE READER	May 10, 1990	Substantially Equivalent	Tosoh Corp.
K901542	E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE	Apr 26, 1990	Substantially Equivalent	Source Scientific Systems, Inc.
K900245	DU PONT VISTA(R) IMMUNOASSAY SYSTEM	Apr 11, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K901059	AUTOMATED EIA MICROPLATE READER MODELS EL340/340I	Apr 09, 1990	Substantially Equivalent	Bio-Tek Instruments, Inc.
K901027	AUTOMATED EIA MICROPLATE READER MODELS EL312/312I	Apr 09, 1990	Substantially Equivalent	Bio-Tek Instruments, Inc.
K900776	NOVAPATH MICROPLATE READER	Apr 03, 1990	Substantially Equivalent	Bio-Rad
K900224	STAT FAX(TM)-2100	Mar 01, 1990	Substantially Equivalent	Awareness Technology, Inc.
K900579	AUTOREADER CALIBRATION TEST PLATE	Feb 27, 1990	Substantially Equivalent	Bio-Tek Instruments, Inc.
K900372	BIOTRACK IMMUNOCHEMISTRY MONITOR	Feb 23, 1990	Substantially Equivalent	Biotrack, Inc.
K900028	ALLERCOAT MICROPLATE SYSTEM	Jan 22, 1990	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K894423	ACC.U.DIAL	Dec 27, 1989	Substantially Equivalent	Exocell, Inc.
K896007	COBAS READY	Dec 19, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K896117	MODIFIED MODEL 535(TM) LUMINOMETER	Nov 30, 1989	Substantially Equivalent	Los Alamos Diagnostics
K894859	LP 400 MICROPLATE READER	Oct 31, 1989	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K895967	FASTEC 901 AGGLUTINATION PATTERN READER	Oct 30, 1989	Substantially Equivalent	Schiff & Co.
K895313	MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER	Oct 17, 1989	Substantially Equivalent	Dynatech Laboratories, Inc.
K895102	BIOTRACK PDS MONITOR	Oct 10, 1989	Substantially Equivalent	Biotrack, Inc.
K894503	GEMTAB SYSTEM	Sep 05, 1989	Substantially Equivalent	Pharmacia Eni Diagnostics, Inc.
K894687	DYNATECH MR 5000, CATALOG #011-976-0600	Aug 31, 1989	Substantially Equivalent	Dynatech Laboratories, Inc.
K894270	DENLEY ANTHOS 2001 READER	Aug 21, 1989	Substantially Equivalent	Denley Instruments, Inc.
K893738	QUIDEL REFLECTANCE ANALYZER	Aug 11, 1989	Substantially Equivalent	Quidel Corp.
K891767	GENETIC SYSTEMS MICROPLATE READER	Jul 25, 1989	Substantially Equivalent	Genetic Systems Corp.
K891270	MICROTRAK EIA AUTOREADER	Jun 16, 1989	Substantially Equivalent	Syva Co.
K892063	THERMOMAX MICROPLATE READER, MODIFICATION	May 11, 1989	Substantially Equivalent	Molecular Devices Corp.
K891869	CLS 962 MICROPLATE PHOTOMETER	May 09, 1989	Substantially Equivalent	Cambridge Life Sciences Plc.
K890854	EIA READER MODEL EL301	Mar 16, 1989	Substantially Equivalent	Bio-Tek Instruments, Inc.
K890502	MICROLITE TUBE LUMINOMETER #011-902-0000	Feb 27, 1989	Substantially Equivalent	Dynatech Laboratories, Inc.
K884782	MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)	Feb 17, 1989	Substantially Equivalent	Dynatech Laboratories, Inc.
K884864	PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO	Feb 10, 1989	Substantially Equivalent	The Perkin-Elmer Corp.
K884124	AUTOMATED EIA READER MODEL EL311	Jan 03, 1989	Substantially Equivalent	Bio-Tek Instruments, Inc.
K883646	BEHRING TURBITIMER	Oct 31, 1988	Substantially Equivalent	Behring Diagnostics, Inc.
K883435	NOVASPEC II SPECTROPHOTOMETER	Oct 13, 1988	Substantially Equivalent	Pharmacia, Inc.
K883302	EMAX PRECISION MICROPLATE READER	Sep 13, 1988	Substantially Equivalent	Molecular Devices Corp.
K882938	STAT FAX(TM)	Sep 09, 1988	Substantially Equivalent	Awareness Technology, Inc.
K882608	LAD MODEL 633 LUMINOMETER	Aug 29, 1988	Substantially Equivalent	Los Alamos Diagnostics
K882095	MODIFICATION OF BEHRING RAPIMAT II/T	Aug 02, 1988	Substantially Equivalent	Behring Diagnostics, Inc.
K881458	ASTROSCAN 2100 MICROTITER PLATE READER	Jun 29, 1988	Substantially Equivalent	Astroscan , Ltd.
K881797	EASY WASHER II MICROPLATE WASHER	Jun 15, 1988	Substantially Equivalent	Slt Labinstruments, Inc.
K881877	COBAS EIA(TM) PHOTOMETER	Jun 10, 1988	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K881803	UVMAX KINETIC MICROPLATE READER	May 31, 1988	Substantially Equivalent	Molecular Devices Corp.
K873893	LUMICON	Jan 05, 1988	Substantially Equivalent	Hamilton Co.
K874262	LAD MODEL 735 LUMINOMETER	Nov 27, 1987	Substantially Equivalent	Los Alamos Diagnostics
K873384	CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA	Nov 20, 1987	Substantially Equivalent	Helena Laboratories
K873451	PROJECT 300 MICROASSAY BP-12, EIA MINILAB	Nov 04, 1987	Substantially Equivalent	Awareness Technology, Inc.
K874244	DYNATECH MR 300 MANUAL MICROELISA	Nov 03, 1987	Substantially Equivalent	Dynatech Laboratories, Inc.
K873678	SPECTROPHOTOMETER (MICROASSAY PLATE READERS)	Sep 29, 1987	Substantially Equivalent	Slt Labinstruments, Inc.
K873638	MICRO-CHEM ANALYZER	Sep 29, 1987	Substantially Equivalent	Ocean Scientific, Inc.
K873583	AUTO-EIA	Sep 22, 1987	Substantially Equivalent	Labsystems, Inc.
K872749	SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000	Sep 16, 1987	Substantially Equivalent	Secomam Co.
K873138	MICRO-READER II	Sep 14, 1987	Substantially Equivalent	Hyperion, Inc.
K873408	MODEL 690 SPECTROPHOTOMETER	Sep 08, 1987	Substantially Equivalent	Abbott Diagnostics
K872219	GEN-PROBE (R) LUMINOMETER - LEADER (TM)	Aug 21, 1987	Substantially Equivalent	Gen-Probe, Inc.
K872324	LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT	Aug 19, 1987	Substantially Equivalent	Berthold Analytical Instruments, Inc.
K871874	CIBA CORNING MAGIC LITE ANALYZER II	May 26, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K871307	SYVA Q-SPEC PHOTOMETER	May 26, 1987	Substantially Equivalent	Syva Co.
K871415	MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)	Apr 22, 1987	Substantially Equivalent	Dynatech Laboratories, Inc.
K864542	ARTEL DIFFERENTIAL PHOTOMETER	Feb 06, 1987	Substantially Equivalent	Artel, Inc.
K864451	UV VISIBLE SPECTROPHOTOMETERS	Feb 06, 1987	Substantially Equivalent	Trans-National Trade Development Corp.
K864566	ADX(TM) ANALYZER	Feb 04, 1987	Substantially Equivalent	Abbott Laboratories
K864201	LAD MODEL 535 LUMINOMETER	Jan 13, 1987	Substantially Equivalent	Los Alamos Diagnostics
K863959	OHMEDA 6000 MULTI-GAS MONITOR	Jan 12, 1987	Substantially Equivalent	Ohmeda Medical
K864285	TERUMO OVATION SPECTROPHOTOMETER	Jan 09, 1987	Substantially Equivalent	Terumo Medical Corp.
K864634	AP1 COLORIMETER	Dec 31, 1986	Substantially Equivalent	Awareness Technology, Inc.
K864319	TDX(R) II ANALYZER	Dec 16, 1986	Substantially Equivalent	Abbott Laboratories
K864060	MICRO-READER	Nov 28, 1986	Substantially Equivalent	Hyperion, Inc.
K863802	VMAX KINETIC MICROPLATE READER	Nov 05, 1986	Substantially Equivalent	Molecular Devices Corp.
K863566	GSC 1000	Oct 16, 1986	Substantially Equivalent	Genetic Systems Corp.
K861263	BEHRING RAPIMAT II	Oct 03, 1986	Substantially Equivalent	Behring Diagnostics, Inc.
K862999	ULTRASCAN CLINICAL ANALYZER	Sep 15, 1986	Substantially Equivalent	Specialty Medical Industries, Inc.
K862908	AKERSCAN COLORIMETRIC ANALYZER	Sep 15, 1986	Substantially Equivalent	Akers Medical Technologies
K861897	UNISKAN II	Jul 01, 1986	Substantially Equivalent	Flow Laboratories, Inc.
K860720	BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)	May 23, 1986	Substantially Equivalent	Biotrack, Inc.
K861617	THE PARTNER SPECTROPHOTOMETER	May 19, 1986	Substantially Equivalent	Pharmacia, Inc.
K861223	THE JR. PARTNER SPECTROPHOTOMETER	May 05, 1986	Substantially Equivalent	Pharmacia, Inc.
K860987	MINI-CHEM ANALYZER	May 05, 1986	Substantially Equivalent	Ocean Scientific, Inc.
K861194	ULTROSPEC K KINETICS SPECTROPHOTOMETER	Apr 24, 1986	Substantially Equivalent	Lkb Instruments, Inc.
K855108	RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR	Feb 21, 1986	Substantially Equivalent	Biomaterials International, Inc.
K854679	PHOTIC-100 SPECTROPHOTOMETER	Feb 20, 1986	Substantially Equivalent	Future Impex Corp.
K855149	COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER	Feb 11, 1986	Substantially Equivalent	Hyperion, Inc.
K854210	TERUMO SENSIBEAD EIA COLORIMETER	Dec 05, 1985	Substantially Equivalent	Terumo Medical Corp.
K854540	RAICHEM/K.E	Nov 26, 1985	Substantially Equivalent	Reagents Applications, Inc.
K854303	MR 700 MICROPLATE READER 012-700-1000	Nov 19, 1985	Substantially Equivalent	Dynatech Laboratories, Inc.
K853284	MYREADER 7	Oct 04, 1985	Substantially Equivalent	Scientific Sales Intl., Inc.
K853453	BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER	Sep 30, 1985	Substantially Equivalent	Bio Automed Systems, Inc.
K852538	LKB 4057 ULTROSPEC II E	Sep 30, 1985	Substantially Equivalent	Lkb Instruments, Inc.
K852411	MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)	Sep 30, 1985	Substantially Equivalent	Dynatech Laboratories, Inc.
K852481	UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM	Aug 21, 1985	Substantially Equivalent	Em Diagnostic Systems, Inc.
K844894	PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES	Jun 25, 1985	Substantially Equivalent	Slt Labinstruments, Inc.
K852047	SC-360 SPECTROPHOTOMETER	May 31, 1985	Substantially Equivalent	Pharmacia, Inc.
K851572	NOVASPEC VISIBLE SPECTROPHOTOMETER	May 20, 1985	Substantially Equivalent	Lkb Instruments, Inc.
K850995	SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P	May 10, 1985	Substantially Equivalent	Awareness Technology, Inc.
K850994	SPECTRA 1 FILTER PHOTOMETER	May 10, 1985	Substantially Equivalent	Awareness Technology, Inc.
K850993	SMART ALEX II MULTI-FILTER PHOTOMETER	May 07, 1985	Substantially Equivalent	Awareness Technology, Inc.
K851098	BEHRING VECTOR PHOTOMETER	Apr 25, 1985	Substantially Equivalent	Behring Diagnostics, Inc.
K850392	INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS	Apr 12, 1985	Substantially Equivalent	Clinical Data, Inc.
K844567	TITERTEK TWINREADER 78-630-00	Mar 21, 1985	Substantially Equivalent	Flow Laboratories, Inc.
K844419	TITERTEK MULTISKAN MSS/340	Mar 21, 1985	Substantially Equivalent	Flow Laboratories, Inc.
K844418	TITERTEK MULTISKAN MCC	Mar 21, 1985	Substantially Equivalent	Flow Laboratories, Inc.
K850767	SPECTRONIC 2000 SPECTROPHOTOMETER	Mar 14, 1985	Substantially Equivalent	Bausch & Lomb, Inc.
K850709	SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER	Mar 12, 1985	Substantially Equivalent	Bausch & Lomb, Inc.
K850348	UROTRON RL9	Mar 12, 1985	Substantially Equivalent	Boehringer Mannheim Corp.
K850708	SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER	Mar 11, 1985	Substantially Equivalent	Bausch & Lomb, Inc.
K842474	GLUCOCHEK III	Feb 12, 1985	Substantially Equivalent	Larken Industries, Inc.
K843668	PHOTOMETER 90IYS	Oct 30, 1984	Substantially Equivalent	Institute Virion , Ltd.
K841648	DIAGEM DIGITAL BLOOD GLUCOSE MONITOR	Oct 11, 1984	Substantially Equivalent	Forward Medical Supplies
K843460	ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER	Sep 26, 1984	Substantially Equivalent	Varian Assoc., Inc.
K842947	MICROBIOLOGICAL TRAY READER-MANUAL	Sep 14, 1984	Substantially Equivalent	American Micro Scan
K842770	MACBETH COLOR EIAD 100/100PC	Sep 14, 1984	Substantially Equivalent	Macbeth
K843296	ELVI 675 DIGITRON	Sep 13, 1984	Substantially Equivalent	Logos Scientific, Inc.
K842311	CHEMISTRY ANALYZER, GEN. PURPOSE	Jul 25, 1984	Substantially Equivalent	Hml Inc/Biotechnology Transfer
K842085	AUTOMATED EIA MICROPLATE READER EL310	Jun 11, 1984	Substantially Equivalent	Bio-Tek Instruments, Inc.
K841557	ORTHO MICROWELL READER	May 22, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K841214	LABSYSTEMS UNISKAN	Apr 13, 1984	Substantially Equivalent	Labsystems, Inc.
K840340	CHEM-STAT ANALYZER	Mar 23, 1984	Substantially Equivalent	Ocean Scientific, Inc.
K834489	ULTROSPEC W/APPLE II -4050-	Feb 10, 1984	Substantially Equivalent	Lkb Instruments, Inc.
K834099	BLOOD GLUCOSE MONITOR	Feb 03, 1984	Substantially Equivalent	Healthdyne, Inc.
K834150	STRIP SPLITTER II -HALF WIDTH CARRIER	Jan 11, 1984	Substantially Equivalent	Larken Industries, Inc.
K832531	PHOTOMETER LP 300	Dec 12, 1983	Substantially Equivalent	Dr. Bruno Lange GmbH
K832397	HYBRITECH 405-500 NM FILTER MODULE	Aug 31, 1983	Substantially Equivalent	Hybritech, Inc.
K832364	PHOTON IMMUNOASSAY ANALYZER	Aug 26, 1983	Substantially Equivalent	Hybritech, Inc.
K832206	SPECTROPHOTOMETER #390	Aug 24, 1983	Substantially Equivalent	Abbott Diagnostics
K831866	MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC	Jul 28, 1983	Substantially Equivalent	Varian Assoc., Inc.
K830569	CYNOX I HEMOGLOBINOMETER	Apr 08, 1983	Substantially Equivalent	Buffalo Medical Specialties Mfg., Inc.
K823512	MR 600 MICROPLATE READER	Mar 01, 1983	Substantially Equivalent	Laboratory and Medical Products Group
K823590	MANUALISA MICROTITRATION PLATE READER	Feb 28, 1983	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K830101	COLORIMETERS SERIES ONE 12	Jan 28, 1983	Substantially Equivalent	Innotron of Oregon, Inc.
K823720	SPECTROPHOTOMETER	Jan 07, 1983	Substantially Equivalent	Macomb Chemical Co.
K823266	POSITIVE I.D. SYSTEM	Dec 15, 1982	Substantially Equivalent	Abbott Laboratories
K822800	PICOLITE	Oct 27, 1982	Substantially Equivalent	United Technologies Packard
K822720	MODEL 340 SPECTROPHOTOMETER	Oct 08, 1982	Substantially Equivalent	Abbott Diagnostics
K822050	STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO	Aug 27, 1982	Substantially Equivalent	Helena Laboratories
K821561	VERSACHEM ANALYZER	Jun 01, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821439	MR 600 MICROPLATE READER	Jun 01, 1982	Substantially Equivalent	Dynatech Corp.
K813563	PHADEZYM ANALYZER	Mar 22, 1982	Substantially Equivalent	Pharmacia, Inc.
K820273	4050/4051 ULTRASPEC	Feb 18, 1982	Substantially Equivalent	Lkb Instruments, Inc.
K820217	LKB-WALLACE 1251 LUMINOMETER	Feb 12, 1982	Substantially Equivalent	Lkb Instruments, Inc.
K812865	QUANTUMATIC DUAL-WAVELENGTH SPECTRO	Nov 10, 1981	Substantially Equivalent	Abbott Laboratories
K811975	MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL	Jul 27, 1981	Substantially Equivalent	Waters Assoc., Inc.
K811680	ACCUDEX	Jul 23, 1981	Substantially Equivalent	Biodynamics Corp.
K811840	BILIRUBINOMETER	Jul 15, 1981	Substantially Equivalent	Advanced Instruments, Inc.
K811806	QUICK-CHEM COLORIMETER	Jul 15, 1981	Substantially Equivalent	The Dow Chemical Co.
K811111	AUTOMATIC ELISA READER	May 08, 1981	Substantially Equivalent	Artek Systems Corp.
K810665	GILUCOCHEK REFLECTANCE METER	Apr 17, 1981	Substantially Equivalent	Lifescan, Inc.
K810736	LUMINESCENCE PHOTOMETER 100 SERIES	Mar 31, 1981	Substantially Equivalent	Sai Technology
K810511	BECKMAN DU-8 SPECTROPHOTOMETER	Mar 06, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K810105	BCA 1000	Feb 02, 1981	Substantially Equivalent	Biodynamics Corp.
K803285	PHOTOMETER	Jan 16, 1981	Substantially Equivalent	Turner Designs, Inc.
K803131	LKB-WALLACE 1250 LUMINOMETER	Jan 15, 1981	Substantially Equivalent	Lkb Instruments, Inc.
K803030	THE BIO-TEK CHROMOSCAN	Dec 22, 1980	Substantially Equivalent	Bio-Tek Instruments, Inc.
K802619	DRUG DETECTION SYSTEM	Oct 31, 1980	Substantially Equivalent	Syva Co.
K801957	MICRO-FLOW SPECTROPHOTOMETER CL-720	Sep 26, 1980	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K801536	BLOOD GLUCOSE TESTER	Sep 16, 1980	Substantially Equivalent	Broomer Research Corp.
K801564	PHOTOMETER LP 1	Aug 20, 1980	Substantially Equivalent	Dr. Bruno Lange GmbH
K801563	PHOTOMETER LP 3	Aug 20, 1980	Substantially Equivalent	Dr. Bruno Lange GmbH
K801562	PHOTOMETER LP 6	Aug 20, 1980	Substantially Equivalent	Dr. Bruno Lange GmbH
K801499	AGA UV PHOTOMETER	Aug 13, 1980	Substantially Equivalent	Syva Co.
K801373	BECKMAN MODEL 42 SPECTROPHOTOMETER	Jul 14, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K801044	AMES GLUCOMETER REFLECT. PHOTOMETER	Jun 02, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K800522	MICRO ELISA AUTO READER	Mar 25, 1980	Substantially Equivalent	Dynatech Laboratories, Inc.
K800523	MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC.	Mar 20, 1980	Substantially Equivalent	Varian Assoc., Inc.
K792647	AUTOSCAN 3	Mar 17, 1980	Substantially Equivalent	Cnr Labs
K800057	MICRO ELISA MINI READER	Feb 11, 1980	Substantially Equivalent	Dynatech Laboratories, Inc.
K792292	AMES DEXTROMETER REFLECTANCE COLORIMETER	Dec 06, 1979	Substantially Equivalent	Miles Laboratories, Inc.
K791968	EIA (ELISA) READER	Oct 17, 1979	Substantially Equivalent	Gilford Instrument Laboratories, Inc.
K791302	MANUAL MICRO ELISA READER #2-530	Aug 16, 1979	Substantially Equivalent	Dynatech Laboratories, Inc.
K791102	CARY 210 SERIES, SPECTROPHOTOMETER	Jul 17, 1979	Substantially Equivalent	Varian Assoc., Inc.
K790422	MULTISKAN (78-503-00)	Apr 20, 1979	Substantially Equivalent	Flow Laboratories, Inc.
K782035	HEMESPEC	Jan 17, 1979	Substantially Equivalent	Helena Laboratories
K781632	UROTRON	Dec 20, 1978	Substantially Equivalent	Boehringer Mannheim Corp.
K781269	ELISA SYSTME	Dec 04, 1978	Substantially Equivalent	Gilford Instrument Laboratories, Inc.
K781576	MINI-KEM	Oct 03, 1978	Substantially Equivalent	Coulter Electronics, Inc.
K781544	EPPENDORF PCP 6121	Oct 03, 1978	Substantially Equivalent	Marilyn L. Amick
K781241	UNISTAT BILIRUBINOMETER	Aug 14, 1978	Substantially Equivalent	American Optical Corp.
K781138	SPECTROPHOTOMETER	Aug 14, 1978	Substantially Equivalent	Bausch & Lomb, Inc.
K780903	CLINICAL ANALYZER SYSTEM	Jun 28, 1978	Substantially Equivalent	Bausch & Lomb, Inc.
K780902	FISHER SPECTROPHOTOMETER	Jun 28, 1978	Substantially Equivalent	Bausch & Lomb, Inc.
K780156	SPECTROPHOTOMETER, MODEL 380	Feb 23, 1978	Substantially Equivalent	Turner Assoc.
K771909	DUAL WAVELENGTH PHOTOMETER, 1177	Dec 20, 1977	Substantially Equivalent	Abbott Laboratories
K771807	SPECTROPHOTOMETER ANALYSIS SYS.	Nov 28, 1977	Substantially Equivalent	Varian Assoc., Inc.
K772022	SPECTROPHOTOMETER CARY 219	Nov 11, 1977	Substantially Equivalent	Varian Assoc., Inc.
K771637	SPECTROPHOTOMETER ANALYSIS SYSTEM	Oct 25, 1977	Substantially Equivalent	Varian Assoc., Inc.
K771496	CHEMCODE/CHEMTEK SYSTEM	Oct 25, 1977	Substantially Equivalent	Boehringer Mannheim Corp.
K770306	ANALYZER, 751 KINETIC/ENDPOINT	Apr 05, 1977	Substantially Equivalent	Sclavo, Inc.
K770288	SPECTROPHOTOMETER, MODEL 597 IR	Mar 10, 1977	Substantially Equivalent	The Perkin-Elmer Corp.
K770278	SPECTROPHOTOMETERS, INFRARED MODELS X99	Mar 10, 1977	Substantially Equivalent	The Perkin-Elmer Corp.
K760737	SCATTERED TRANSMISSION ACCESSORY	Nov 24, 1976	Substantially Equivalent	The Perkin-Elmer Corp.
K760553	PRINTER	Nov 01, 1976	Substantially Equivalent	Turner Assoc.
K760395	PHOTOMETER, SEROMETER (MODEL 380)	Nov 01, 1976	Substantially Equivalent	Mallinckrodt Critical Care
K760672	CLINICAL SPECTROPHOTOMETER	Oct 29, 1976	Substantially Equivalent	The Dow Chemical Co.
K760233	TABLE, SAMPLE IL 461	Aug 26, 1976	Substantially Equivalent	Instrumentation Laboratory CO
K760232	PRINTER, IL 460	Aug 26, 1976	Substantially Equivalent	Instrumentation Laboratory CO
K760112	SPECTROPHOTOMETER (JUNIOR III)	Jul 16, 1976	Substantially Equivalent	The Perkin-Elmer Corp.