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

Wampole Laboratories — Predicate Candidate Screening

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

82 daysmedian FDA review time

112 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K965131	BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM	Wampole Laboratories	1997-03-26	93
K965129	BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM	Wampole Laboratories	1997-03-26	93
K911444	RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM	Wampole Laboratories	1991-08-30	151
K882896	ONE-STEP HCG	Wampole Laboratories	1988-10-31	112
K883004	MONO-PLUS(TM)	Wampole Laboratories	1988-08-04	17
K875101	VIROGEN CMV ANTIBODY TEST	Wampole Laboratories	1988-03-01	82
K875161	MAT (TM) MICROALBUMIN TEST	Wampole Laboratories	1988-02-17	64
K791309	UCG-LYPHOTEST	Wampole Laboratories	1979-07-30	14
K790986	RF CONTROLS	Wampole Laboratories	1979-06-28	34
K781794	BETA-TEC	Wampole Laboratories	1978-12-29	65
K760336	BIOCEPT-G	Wampole Laboratories	1976-11-12	105
K760681	INDIRECT FLUORESCENT (IFA-ANA)	Wampole Laboratories	1976-10-21	31

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