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

Mrl Diagnostics — Predicate Candidate Screening

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

203 daysmedian FDA review time

439 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K000238	HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G	Mrl Diagnostics	2000-04-14	78	1
K993754	HSV-1 ELISA IGG, MODEL EL0910G	Mrl Diagnostics	2000-02-09	96	0
K993724	HSV-2 ELISA IGG, MODEL EL0920G	Mrl Diagnostics	2000-02-01	90	0
K971007	LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB	Mrl Diagnostics	1998-06-01	439	0
K971006	LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB	Mrl Diagnostics	1998-06-01	439	0
K946353	EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORES	Mrl Diagnostics	1995-07-21	203	0
K931520	EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY	Mrl Diagnostics	1994-04-26	396	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