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

Genus Diagnostics — Predicate Candidate Screening

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

18 daysmedian FDA review time

85 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K854974	HSV IDR	Genus Diagnostics	1986-03-07	85
K852204	MCCOY GENCELLS	Genus Diagnostics	1985-06-04	14
K852206	HEP-2 GENCELLS	Genus Diagnostics	1985-06-04	14
K852205	RMK GENCELLS CULTURE SYSTEM	Genus Diagnostics	1985-06-04	14
K851928	HEK GENCELLS	Genus Diagnostics	1985-05-20	18
K851927	VERO GENCELLS	Genus Diagnostics	1985-05-20	18
K851562	MRC-5 GENCELLS	Genus Diagnostics	1985-05-10	24
K851561	WI-38 GENCELLS	Genus Diagnostics	1985-05-10	24
K851563	RK GENCELLS	Genus Diagnostics	1985-05-10	24

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