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

Biogenex Laboratories — Predicate Candidate Screening

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

62 daysmedian FDA review time

161 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K012960	BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR	Biogenex Laboratories	2002-03-08	185
K013148	BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)	Biogenex Laboratories	2002-02-28	161
K925189	PREGNAGEN 1-STEP PREGNANCY TEST	Biogenex Laboratories	1993-01-06	85
K902208	MODIFIED OVUGEN	Biogenex Laboratories	1990-07-17	62
K884880	PREGNAGEN(TM)	Biogenex Laboratories	1989-01-13	53
K882002	PREGNAGEN(TM)	Biogenex Laboratories	1988-09-09	119
K873534	OVUGEN SURETEST	Biogenex Laboratories	1987-11-23	83
K831221	RIAGEN B-HCG RIA KIT	Biogenex Laboratories	1983-06-02	48
K821657	RIAGEN B-HCG RIA	Biogenex Laboratories	1982-07-13	39
K821234	RIAGEN B-HCG RIA	Biogenex Laboratories	1982-05-21	23
K820724	FLUOROGEN PAP FIA	Biogenex Laboratories	1982-04-14	28
K813261	RIAGEN PAP RIA	Biogenex Laboratories	1981-12-17	27

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