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

Clinical Diagnostics, Inc. — Predicate Candidate Screening

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

175 daysmedian FDA review time
368 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971653GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEMClinical Diagnostics, Inc.1998-01-022410
K951457GLUCOCHEK POCKETLABClinical Diagnostics, Inc.1996-02-223300
K940215GLUCOCHEKClinical Diagnostics, Inc.1995-01-173680
K854903GORDON DIAGNOSTIC SYSTEM MODEL IClinical Diagnostics, Inc.1986-06-021750
K771813CENTRIFICHEM SYS 400 ANALYZERClinical Diagnostics, Inc.1977-10-25280
K771118CENTRIA SEPARATION COLUMNS TYPE AClinical Diagnostics, Inc.1977-07-11200
K771117CENTRIA CORTISOL RIAClinical Diagnostics, Inc.1977-06-2320
K761272CENTRIA T4 RIAClinical Diagnostics, Inc.1977-03-16860

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