Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LJC — Predicate Candidate Screening

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

105 daysmedian FDA review time

302 days90th percentile

67clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K032330	CT OIA	Thermo Biostar, Inc.	2004-03-02	217	0
K033865	IDEIA PCE CHLAMYDIA	Dakocytomation, Ltd.	2004-01-21	40	0
K033079	CHLAMYDIA IGG ELISA TEST SYSTEM	Trinity Biotech USA	2003-11-26	58	0
K982210	MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA	Dade Behring, Inc.	1998-07-09	16	0
K962558	CHLAMYDIA IGG ELISA TEST SYSTEM	Armkel, LLC	1997-02-24	238	0
K960850	ACCESS CHLAMYDIA ASSAY	Bio-Rad Laboratories, Inc.	1997-02-04	340	0
K955627	VIDAS CHLAMYDIA BLOCKING ASSAY	Biomerieux Vitek, Inc.	1996-10-07	301	0
K936054	IMX SELECT CHLAMYDIA	Abbott Laboratories	1996-05-30	891	0
K940564	IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION	Dako Diagnostics , Ltd.	1996-01-11	707	0
K951010	CHLAMYDIA OIA	Biostar, Inc.	1995-10-07	215	2
K946276	QUICKVUE(R) CHLAMYDIA TEST	Quidel Corp.	1995-05-19	147	0
K935807	ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY	Bio-Rad Laboratories, Inc.	1995-05-19	533	0
K935393	CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING A	Bio-Rad Laboratories, Inc.	1994-09-20	316	0
K926090	SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT	Syva Co.	1993-09-30	302	0
K921747	MICRO TRAK XL SYSTEM	Syva Co.	1992-10-01	171	0
K920503	SYVA MICROTRAK CHLAMYDIA EIA	Syva Co.	1992-09-25	233	0
K921462	MICROTRAK(R) II CHLAMYDIA EIA ASSAY	Syva Co.	1992-09-25	182	0
K921321	ORTHO CHLAMYDIA ANTIGEN ELISA TEST	Ortho Diagnostic Systems, Inc.	1992-08-11	148	0
K914327	SEROELISA(TM) CHLAMYDIA IGA TEST KIT	Savyon Diagnostics , Ltd.	1992-06-09	256	0
K915281	SEROLISA CHLAMYDIA IGG TEST KIT	Savyon Diagnostics , Ltd.	1992-03-23	119	0
K915884	VIDAS CHLAMYDIA ASSAY, MODIFICATION	Vitek Systems, Inc.	1992-03-04	83	1
K912680	ANTIGENZ CHLAMYDIA	Baxter Diagnostics, Inc.	1991-07-22	49	0
K905787	VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST	Vitek Systems, Inc.	1991-04-29	123	1
K904189	CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1991-03-27	196	0
K910668	ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION	Ortho Diagnostic Systems, Inc.	1991-03-19	34	0
K905179	SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION	Syva Co.	1991-03-12	113	0
K904725	CHLAMYDIA SYSTEM SOFTWARE (CSS)	Kallestad Diag, A Div. of Erbamont, Inc.	1991-01-14	89	0
K903132	ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF	Ortho Diagnostic Systems, Inc.	1990-12-21	157	0
K903765	QUIDEL CHLAMYDIA POSITIVE CONTROL	Quidel Corp.	1990-10-02	46	0
K903758	SYVA MICROTRAK EIA ACCESSORY REAGENTS	Syva Co.	1990-09-12	23	0
K901972	ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA	Novo Nordisk Diagnostics, Ltd.	1990-09-05	127	0
K902270	CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1990-07-31	71	0
K901660	QUIDEL CHLAMYDIA TEST	Quidel Corp.	1990-07-27	108	0
K902253	PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT	Kallestad Diag, A Div. of Erbamont, Inc.	1990-07-26	66	0
K901934	KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET	Eastman Kodak Company	1990-06-20	51	0
K900973	VISUWELL(R) CHLAMYDIA	Adi Diagnostics, Inc.	1990-05-15	74	0
K900543	CHLAMYDIAZYME DIAGNOSTIC KIT	Abbott Laboratories	1990-05-03	87	0
K895468	ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG	Orgenics, Ltd.	1990-03-13	183	0
K900402	ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT	Eastman Kodak Company	1990-03-08	38	0
K896032	MODIFIED ELISA FOR CHLAMYDIA	Fairleigh Dickinson Laboratories, Inc.	1990-01-29	105	0
K895280	CLEARVIEW CHLAMYDIA	Unipath , Ltd.	1990-01-29	158	0
K895505	KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)	Eastman Kodak Company	1990-01-02	113	0
K895122	CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1989-10-30	76	0
K893676	ABBOTT TESTPACK CHLAMYDIA	Abbott Laboratories	1989-07-25	70	0
K892371	CHLAMYDIAZYME BLOCKING REAGENT	Abbott Laboratories	1989-06-02	57	0
K890196	MICROTRAK CHLAMYDIA EIA	Syva Co.	1989-03-22	63	0
K885006	CHLAMYDIAZYME/COMMANDER INSTRUMENTATION	Abbott Laboratories	1988-12-16	14	0
K880799	MODIFIED IDEIA CHLAMYDIA TEST	Boots-Celltech Diagnostics, Inc.	1988-12-08	283	0
K884517	PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED	Kallestad Diag, A Div. of Erbamont, Inc.	1988-11-30	34	0
K882923	KODAK SURECELL CHLAMYDIA TEST KIT	Eastman Kodak Company	1988-11-10	120	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