Atlas FDA

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

Irvine Diagnostic Services — Predicate Candidate Screening

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

14 daysmedian FDA review time
15 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K842871HIPPURATE TEST REAGENTIrvine Diagnostic Services1984-08-07150
K842869DECARBOXYLASE TEST REAGENTIrvine Diagnostic Services1984-08-07150
K842870VOGES-PROSKAUER REAGENT AIrvine Diagnostic Services1984-08-03110
K842868HIPPURATE TEST DISKSIrvine Diagnostic Services1984-08-03110
K842872INDOLE REAGENTIrvine Diagnostic Services1984-08-03110
K842867VOGES-PROSKAUER REAGENT BIrvine Diagnostic Services1984-08-03110
K842299ZINC DUST SUSPENSIONIrvine Diagnostic Services1984-06-26150
K842298OXIDASE TEST STRIPS-OXIDASESUREIrvine Diagnostic Services1984-06-25140
K842300ONPG DISKSIrvine Diagnostic Services1984-06-22110
K842072L-ALANINE-4-NITROANILIDEIrvine Diagnostic Services1984-06-07150

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