Atlas FDA

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

GNM — Predicate Candidate Screening

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

617 daysmedian FDA review time
627 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K936254COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODYLight Diagnostics1995-09-086170
K936251COXSACKIEVIRUS B3 MONOCLONAL ANTIBODYLight Diagnostics1995-09-086170
K936073ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUSChemicon Intl., Inc.1995-09-086270
K940471COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIESChemicon Intl., Inc.1995-09-085830
K936089COXSACKIE A24 VIRUS MONOCLONAL ANTIBODYChemicon Intl., Inc.1995-09-086260
K936252COXSACKIEVIRUS B@ MONOCLONAL ANTIBODYLight Diagnostics1995-09-086170
K936253COXSACKIEVIRUS B4 MONOCLONAL ANTIBODYLight Diagnostics1995-09-086170
K940472COXSACKIEVIRUS B5 MONOCLONAL ANTIBODYChemicon Intl., Inc.1995-09-085830
K936145COXSACKIEVIRUS B1 MONOCLONAL ANTIBODYChemicon Intl., Inc.1995-09-086200

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