Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

JJQ — Predicate Candidate Screening

258 FDA 510(k) clearances under this product code; the 50 most recent screened below.

47 daysmedian FDA review time

144 days90th percentile

258clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K013371	UBIT-IR300 INFRARED SPECTROMETRY SYSTEM	Otsuka Pharmaceutical Co., Ltd.	2001-12-21	71	1
K980120	DIGENE DML 2000 MICROPLATE LUMINOMETER	Digene Corp.	1998-02-06	24	0
K973938	ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER	Sfri, Inc.	1998-02-04	112	0
K974762	STAT TRACKS	Awareness Technology, Inc.	1998-01-28	40	0
K962113	ANTHOS PHACTS VERSION MICROPLATE READER	Columbia Bioscience, Inc.	1996-11-05	158	0
K961183	CBI 7520 READER	Columbia Bioscience, Inc.	1996-08-02	129	0
K962166	ORIGEN ANALYZER	Igen, Inc.	1996-07-31	57	0
K955077	ANTHOS 2010 READER	Anthos Labtec, Inc.	1995-12-04	28	0
K953710	ELX808 AUTOMATED MICROPLATE READERS	Bio-Tek Instruments, Inc.	1995-10-25	77	1
K953572	ELX800UV	Bio-Tek Instruments, Inc.	1995-10-19	80	0
K953005	BILI-METER	Olympic Medical Corp.	1995-09-28	92	0
K950029	5STRATEC SL 300 LIA-MAT	Nichols Institute Diagnostics	1995-08-02	210	0
K940486	DIGENE DCR-1 LUMINOMETER	Digene Diagnostics, Inc.	1995-04-18	440	0
K942250	BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER	Biowhittaker Molecular Applications, Inc.	1995-04-04	330	0
K942361	WHITSOFT	Biowhittaker Molecular Applications, Inc.	1995-04-04	322	0
K942245	BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE	Biowhittaker Molecular Applications, Inc.	1995-04-03	329	0
K950104	ELX800 AND EL800 AUTOMATED MICROPLATE READERS	Bio-Tek Instruments, Inc.	1995-03-21	69	1
K942923	CERES 900C & CERES UV900C	Bio-Tek Instruments, Inc.	1995-02-06	230	0
K943454	PLATO 3300/1300	Rosys, Inc.	1995-01-09	175	0
K935983	MICROREADER 4	Hyperion, Inc.	1994-12-09	360	0
K943595	SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM	Instrumentation Laboratory CO	1994-11-28	126	0
K941050	DUPONT ACA STAR	Dupont Medical Products	1994-11-10	248	0
K943701	MRX MICROPLATE READER	Dynatech Laboratories, Inc.	1994-10-20	83	0
K932778	BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER	Boehringer Mannheim Corp.	1993-11-17	162	0
K932467	ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM	Instrumentation Laboratory CO	1993-11-05	165	0
K921536	ACCULYTE CHEMILUMINESCENCE ANALYZER	Laboratory Technologies, Inc.	1993-10-12	580	0
K931907	ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III	Anthos Labtec Instruments	1993-09-29	167	0
K925625	OMNI	Bio-Tek Instruments, Inc.	1993-08-19	286	0
K925935	OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER	Olympus Corp.	1993-04-22	154	0
K923844	LYRIS 100/120 LABORATORY INFORMATION SYSTEM	Biovation, Inc.	1992-12-11	133	0
K925203	TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1	Heraeus Kulzer, Inc.	1992-11-25	97	0
K923158	LUMICO ANALYZER SA-300	Maruzen Petrochemical Co., Ltd.	1992-11-17	141	0
K922329	BERTHOLD LB 954	Eg&G Berthold Analytical Instruments, Inc.	1992-11-16	188	0
K922976	LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT	Eg&G Berthold Analytical Instruments, Inc.	1992-11-16	171	0
K923456	MICROLITE MICROTITER PLATE LUMINOMETER ML3000	Dynatech Laboratories, Inc.	1992-10-13	91	0
K922081	LABOTECH AUTOMATED MICROTITER ANALYZER	Innovative Medical Systems, Inc.	1992-09-02	120	0
K921180	COBAS CORE IMMUNOCHEMISTRY SYSTEM	Roche Diagnostic Systems, Inc.	1992-07-28	140	0
K915896	MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI	Dynatech Laboratories, Inc.	1992-05-04	137	0
K915689	SLT SPECTRA	Slt Labinstruments, Inc.	1992-04-22	121	0
K915690	SLT 340 ATTC	Slt Labinstruments, Inc.	1992-04-22	121	0
K920914	MP/S SINGLE WAVELENGTH MINI PHOTOMETER	Artel, Inc.	1992-03-23	25	0
K915113	ENCORE	Heraeus Kulzer, Inc.	1992-03-18	126	0
K915680	AMERLITE PROCESSING CENTER	Eastman Kodak Company	1992-03-11	83	0
K914906	AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT	Bio-Tek Instruments, Inc.	1991-11-27	26	0
K913590	MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER	Dynatech Laboratories, Inc.	1991-10-25	74	0
K914202	BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE	Baxter Diagnostics, Inc.	1991-10-11	22	0
K913840	MICROTAK PLUS	Syva Co.	1991-09-30	35	0
K912368	IMX SELECT ANALYZER	Abbott Laboratories	1991-09-11	105	0
K913295	OPUS(R) PLUS ANALYZER	Pb Diagnostic Systems, Inc.	1991-09-11	49	0
K910806	METROLAB MODEL 1500	Laboratorio Rodriguez Corswant S.R.L.	1991-08-30	185	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda