Atlas FDA

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

Clinetics Corp. — Predicate Candidate Screening

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

42 daysmedian FDA review time
188 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K862180MODIFIED COTROPIN RADIOIMMUNOASSAY KITClinetics Corp.1986-07-07280
K844066COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSHClinetics Corp.1985-01-18920
K841580TSH RECEPTOR ANTIBODY KIT 125I TSHClinetics Corp.1984-10-221880
K833934ADRENOCORTICOTROPIC HORMONE TESTClinetics Corp.1984-04-041420
K830357RADIOIMMUNOASSAY IMMUNOGLOBULINS D.EClinetics Corp.1983-03-17420
K823379125-I FSH RADIOIMMUNOASSAY KITClinetics Corp.1982-12-22400
K823380125-I LH RADIOIMMUNOASSAY KITClinetics Corp.1982-12-22400
K822152HCG BETA RIA KITClinetics Corp.1982-09-02410
K801306CLINETICS PCA COLUMNClinetics Corp.1980-09-261150

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