Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

MCD · Predicate Candidate Screening

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

143 daysmedian FDA review time
346 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K984126THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TZeus Scientific, Inc.1999-01-11540
K933251EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TESTVirion (U.S.), Inc.1994-06-133460
K925689MERIDIAN EBV-IGG TEST KITFuller Laboratories, Inc.1993-10-123340
K924091EBV-VCA IGG ELISA TEST SYSTEMZeus Scientific, Inc.1993-01-111510
K920412MODIFIED ORTHO EBV VCA-IGG ELISAOrtho Diagnostic Systems, Inc.1992-06-221430
K911570EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.1991-06-10630
K911571EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.1991-06-10630
K910872EBV IGG ELISA TESTGull Laboratories, Inc.1991-04-12420

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