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

Pharmacia Diagnostics, Inc. — Predicate Candidate Screening

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

80 daysmedian FDA review time
146 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K921011PHARMACIA CMV IGM ELISAPharmacia Diagnostics, Inc.1992-07-271460
K920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNOPharmacia Diagnostics, Inc.1992-07-081410
K915348EBV-VCA IGM ELISAPharmacia Diagnostics, Inc.1992-02-14800
K914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSPharmacia Diagnostics, Inc.1992-01-271400
K912026DELFIA(R) 17 -OH-PROGESTERON KITPharmacia Diagnostics, Inc.1991-06-25490
K902793RUBELLA IGGPharmacia Diagnostics, Inc.1990-07-31350
K902792TOXOPLASMA GONDII IGGPharmacia Diagnostics, Inc.1990-07-24280

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