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

GQL — Predicate Candidate Screening

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

94 daysmedian FDA review time

303 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days
K091753	ELVIS HSV ID AND D3 TYPING TEST SYSTEM	Diagnostic Hybrids, Inc.	2009-08-28	73
K081527	LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT	Millipore Corporation	2009-04-01	303
K984120	THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST	Zeus Scientific, Inc.	1999-05-26	189
K984135	THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TES	Zeus Scientific, Inc.	1999-05-26	189
K905608	INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1	Stellar Bio Systems, Inc.	1991-11-07	328
K904095	HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING	California Integrated Diagnostics, Inc.	1991-02-01	148
K904167	PATHODX HERPES TYPING	Diagnostic Products Corp.	1990-12-13	93
K902661	BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2	Baxter Healthcare Corp	1990-07-31	43
K902662	BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST	Baxter Healthcare Corp	1990-07-31	43
K891782	HSV-2 ELISA TEST SYSTEM	Zeus Scientific, Inc.	1989-06-20	88
K891162	HSV-1 ELISA TEST SYSTEM	Zeus Scientific, Inc.	1989-06-20	106
K891382	ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES	Ortho Diagnostic Systems, Inc.	1989-06-06	89
K870814	HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2	Microscan Div. Baxter Healthcare Corp.	1987-06-04	93
K851635	DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST	Diagnon Corp.	1985-10-10	175
K852360	ORTHO DNA PROBE HSV CONFIRMATION TEST	Ortho Diagnostic Systems, Inc.	1985-09-12	100
K852125	PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP	Kallestad Laboratories, Inc.	1985-07-30	76
K851372	CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS	Difco Laboratories, Inc.	1985-07-12	95
K841943	GIBCO HERPES ID KIT	Gibco Laboratories Life Technologies, Inc.	1985-03-13	306
K850739	AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT	Syva Co.	1985-03-11	24
K842216	CULTURESET HSV ISOLATION & ID SYS	Ortho Diagnostic Systems, Inc.	1985-01-29	239
K841190	MICROTRAK HSV 1 & 2 DIRECT SPECIMAN	Syva Co.	1985-01-18	303
K841680	SCOTT SELECTICULT-HSV ISOLATION &	Scott Laboratories, Inc.	1984-10-30	190
K840494	MICROTRAK HSV 1 & 2 CULTURE	Syva Co.	1984-05-07	91
K831504	HERPES IDENT. & TYPING TEST HITT	Electro-Nucleonics Laboratories, Inc.	1983-09-20	132
K830865	HSV IGM TEST	Gull Laboratories, Inc.	1983-07-18	122
K830623	INDIRECT FLUORO-KIT HSV	Clinical Sciences, Inc.	1983-07-07	129
K830971	HERPES SIMPLEX VIRUS TYPING REAGENTS	Immulok, Inc.	1983-06-30	94
K830953	MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION	Syva Co.	1983-06-22	89
K822785	FLUOROSET IMMUNOFLUORESCENT ANTIBODY	Immulok, Inc.	1982-11-29	76
K821411	HISTOSET IMMUNOPEROFIDASE TISSUE	Immulok, Inc.	1982-06-25	44
K821567	IMMULOK CULTURESET	Immulok, Inc.	1982-06-25	31
K812085	HERPES VIRUS HOMINIS ANTIBODY TEST SYS.	Zeus Scientific, Inc.	1981-09-01	41
K802590	DIRECT FLUORESCENT ANTIBODY KIT/HERPES	Bartels & Stout, Inc.	1981-02-09	117
K803132	HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT	Microbiological Research Corp.	1981-01-28	47
K792559	FIAX TEST KIT FOR HERPES SIMPLEX VIRUS	Intl. Diagnostic Technology	1980-03-03	83
K771445	HERPES I.D. TM TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-12-14	135
K771063	HSV TEST	Gull Laboratories, Inc.	1977-07-11	28

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