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

The Upjohn Co. — Predicate Candidate Screening

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

39 daysmedian FDA review time
91 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902004TROBICIN SUSCEPTIBILITY POWDERThe Upjohn Co.1990-05-15390
K900455ZEFAZONE SUSCEPTIBILITY POWDERThe Upjohn Co.1990-02-09100
K810853CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KITThe Upjohn Co.1981-05-29600
K782009RIA KIT, PROGESTERONEThe Upjohn Co.1979-03-02910
K780792TESTOSTERONE RADIOIMMUNOASSAY KIT 125IThe Upjohn Co.1978-06-13290
K760920CAT-A-KITThe Upjohn Co.1976-11-09120

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