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

Clark Laboratories, Inc. — Predicate Candidate Screening

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

155 daysmedian FDA review time
225 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980596VCA IGM ELISA TEST SYSTEMClark Laboratories, Inc.1998-07-221550
K980912VCA IGG ELISA TEST SYSTEMClark Laboratories, Inc.1998-07-221340
K980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.1998-05-01730
K973123EA-D IGG ELISA TEST SYSTEMClark Laboratories, Inc.1998-03-262180
K931543ENCORE ENA COMBINED EIAClark Laboratories, Inc.1993-09-081630
K925826ENCORE THYROGLOBULIN IGE, IGA AND IGM EIAClark Laboratories, Inc.1993-01-26710
K923537ENCORE DS-DNAClark Laboratories, Inc.1992-12-231600
K921870ENCORE SM/RNPClark Laboratories, Inc.1992-12-012250
K921572ENCORE SMClark Laboratories, Inc.1992-12-012430
K922340ENCORE SS-BClark Laboratories, Inc.1992-10-161500
K922157ENCORE SS-AClark Laboratories, Inc.1992-10-131590
K924056ENCORE RHEUMATOID FACTOR EIAClark Laboratories, Inc.1992-09-25440
K921573RUBELLA IGMClark Laboratories, Inc.1992-08-271470
K920150ENCORE SCL-70Clark Laboratories, Inc.1992-03-18650

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