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

LJP — Predicate Candidate Screening

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

75 daysmedian FDA review time

121 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days
K063675	DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION K	Diagnostic Hybrids, Inc.	2007-09-24	287
K941714	CHLAMYDIA TRACHOMATIS ANTIGEN TEST	Neogenex	1994-07-18	117
K901243	CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST	Cel Labs Pty, Ltd.	1990-05-21	67
K900870	PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST	Diagnostic Products Corp.	1990-04-16	51
K895839	PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1	Diagnostic Products Corp.	1990-02-01	121
K883352	FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI	Whittaker Bioproducts, Inc.	1988-10-06	58
K881500	ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST	Ortho Diagnostic Systems, Inc.	1988-04-27	16
K880031	PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS	Kallestad Diag, A Div. of Erbamont, Inc.	1988-03-17	72
K872744	MODIFIED CHLAMYSET ANTIGEN	Orion Corp.	1987-09-22	74
K872903	MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.	Syva Co.	1987-08-06	10
K870946	MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST	Serono Diagnostics, Inc.	1987-04-29	51
K864128	CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT	Diagnostic Technology, Inc.	1987-04-29	190
K871278	MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT	California Integrated Diagnostics, Inc.	1987-04-08	8
K864662	CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS	American Micro Scan	1987-03-25	117
K864539	MODIFIED IMAGEN(TM) CHLAMYDIA TEST	Boots-Celltech Diagnostics, Inc.	1987-03-12	113
K864888	MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST	Syva Co.	1987-02-25	75
K864663	PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM	Kallestad Diag, A Div. of Erbamont, Inc.	1987-02-02	66
K864389	CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST	American Micro Scan	1986-12-04	28
K863681	PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM	Kallestad Laboratories, Inc.	1986-12-03	75
K862354	MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT	Synbiotics Corp.	1986-09-29	101
K862320	DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM	Difco Laboratories, Inc.	1986-08-19	62
K853401	CHLAMYSET ANTIGEN	Orion Corp.	1986-04-28	259
K860179	CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT	Difco Laboratories, Inc.	1986-03-10	52
K853738	ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST	Ortho Diagnostic Systems, Inc.	1985-12-06	91
K852779	MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST	Syva Co.	1985-09-16	77
K851033	SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT	Syncor Intl. Corp.	1985-06-21	101
K850158	CHLAMYDIA FLUORO-KIT 1680	Clinical Sciences, Inc.	1985-03-21	65
K844582	SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST	Syncor Intl. Corp.	1985-01-16	54
K842525	AMIZYME-C TRACHOMATIS TEST KIT	Amico Lab, Inc.	1984-10-01	95
K842658	ANTI-CHLAMYDIA TRACHOMATIS KIT	Amico Lab, Inc.	1984-10-01	83
K842623	MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT	Syva Co.	1984-08-02	28
K834242	ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS	Apple Diagnostic Products	1984-03-02	87
K832078	MICRO TRAK CHLAMYDIA TRAC CONTROL SLID	Syva Co.	1983-09-29	93
K832077	MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT	Syva Co.	1983-09-29	93
K823010	MICRO TRAK CHLAMYDIA TRACHOMATIS CULT	Syva Co.	1982-12-15	64

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