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

General Diagnostics — Predicate Candidate Screening

39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

34 daysmedian FDA review time

91 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K882663	BARBITURATE ENZYME IMMUNOASSAY KIT	General Diagnostics	1988-09-19	84	0
K872882	CANNABINOID ENZYME IMMUNOASSAY KIT	General Diagnostics	1987-11-03	104	0
K871305	COCAINE METABOLITE ENZYME IMMUNOASSAY KIT	General Diagnostics	1987-06-05	65	0
K864993	QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE	General Diagnostics	1987-03-31	99	0
K863877	BENZODIAZEPINE ENZYME IMMUNOASSAY KIT	General Diagnostics	1987-03-12	157	0
K842307	GENERAL DIAG. CEFONICID 30MCG ANTIMIC	General Diagnostics	1984-07-20	38	0
K841465	GENERAL DIAGNOSTICS PLATELET ANTIBODY	General Diagnostics	1984-07-02	84	0
K833709	CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK	General Diagnostics	1983-12-30	71	0
K832653	CEFUROXIME 30MCG. SUSCEP DISK	General Diagnostics	1983-10-14	67	0
K831179	CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP	General Diagnostics	1983-05-09	28	0
K830731	NETILMICIN 30 MCG ANTIMICROBIAL DISK	General Diagnostics	1983-04-08	31	0
K823453	VON WILLEBRAND FACTOR ASSAY	General Diagnostics	1983-01-21	65	0
K823794	CONTROL TM 8	General Diagnostics	1983-01-14	29	0
K822809	AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC	General Diagnostics	1982-11-22	63	0
K821229	CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK	General Diagnostics	1982-06-22	56	0
K820468	PROFILE GENERAL SET ASSAYED SERUM CONTR	General Diagnostics	1982-03-25	31	0
K820019	PIPERACILLIN 100MCG. ANTIMICROBIAL	General Diagnostics	1982-01-29	24	0
K813564	COAG-A-MATE X2	General Diagnostics	1982-01-28	37	0
K812994	MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK	General Diagnostics	1981-12-17	52	0
K812993	MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK	General Diagnostics	1981-11-10	15	0
K812916	MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D	General Diagnostics	1981-11-06	18	0
K812783	TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK	General Diagnostics	1981-10-23	18	0
K803036	PROFILE CARDIAC SET ASSAYED SERUM CONTR.	General Diagnostics	1980-12-22	21	0
K803039	PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.	General Diagnostics	1980-12-22	21	0
K802117	FIBRI QUIK	General Diagnostics	1980-09-26	22	1
K800925	VERIFY S PROD. #34141	General Diagnostics	1980-07-21	91	0
K800926	THROMBOQUIK THROMBIN REAGENT PROD. #3551	General Diagnostics	1980-05-08	17	0
K792479	CHEM-STRATE AMYLASE	General Diagnostics	1979-12-27	24	0
K792477	CHEM-STRATE CK-NAC	General Diagnostics	1979-12-27	24	0
K792480	CHEM-STRATE TRIGLYCERIDE	General Diagnostics	1979-12-27	24	0
K792478	CHEM-STRATE CHOLESTEROL	General Diagnostics	1979-12-27	24	0
K790372	H-D-EL	General Diagnostics	1979-05-03	69	0
K790323	COAG-A-MATE 2001	General Diagnostics	1979-03-21	34	0
K781781	HEPARSORB	General Diagnostics	1979-01-10	83	0
K781814	SULFATE, FIBRIQUIK PROTAMINE	General Diagnostics	1978-11-08	13	0
K780285	SOLUBLE COLLAGEN	General Diagnostics	1978-03-30	37	0
K772106	PH CALIBRATION BUFFERS	General Diagnostics	1977-12-06	29	0
K761250	SIMPLATE	General Diagnostics	1977-03-01	78	0
K760790	MICRO-ID	General Diagnostics	1976-10-29	22	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