Atlas FDA

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

Diagnostic Specialties — Predicate Candidate Screening

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

90 daysmedian FDA review time
183 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITDiagnostic Specialties1997-09-021330
K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic Specialties1994-08-301820
K930823PROTEIN-BOUND GLUCOSE ASSAYN KITDiagnostic Specialties1993-08-191830
K922032ENZIP URINARY MICROALBUMIN TESTDiagnostic Specialties1992-07-30900
K831180PREGNA-CERT, SLIDE PREGNANCY TESTDiagnostic Specialties1983-05-27460
K823109GENERIC PREGNANCY TESTDiagnostic Specialties1982-11-10200
K813608POTASSIUM REAGENT SETDiagnostic Specialties1982-01-22240
K813412GLUCOSE ENZYME-COLOR REAGENT SETDiagnostic Specialties1981-12-31270

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