Atlas FDA

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

Chembio Diagnostic Systems, Inc. — Predicate Candidate Screening

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

97 daysmedian FDA review time
256 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011550HCG STAT PAK ULTRA-FASTChembio Diagnostic Systems, Inc.2001-08-14880
K011551SURE CHECK PREGNANCY TESTChembio Diagnostic Systems, Inc.2001-08-14880
K010244SURE CHECK OVULATION PREDICTORChembio Diagnostic Systems, Inc.2001-05-02970
K981913PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAYChembio Diagnostic Systems, Inc.1999-02-122560
K961965SURE CHECK PREGNANCY TESTChembio Diagnostic Systems, Inc.1996-06-24351
K923925HCG STAT-PAKChembio Diagnostic Systems, Inc.1992-12-241410

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