Atlas FDA

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

Alta Diagnostics, Inc. — Predicate Candidate Screening

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

50 daysmedian FDA review time
84 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K800327MAGNESIUM REAGENTAlta Diagnostics, Inc.1980-03-25420
K792545URIC ACID KITAlta Diagnostics, Inc.1980-01-29500
K792546FETAL CHECKAlta Diagnostics, Inc.1979-12-1880
K790797AMYLASE REAGENT SETAlta Diagnostics, Inc.1979-07-17840
K790796LIPASE REAGENT SETAlta Diagnostics, Inc.1979-07-17840

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