Atlas FDA

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

Quality Assurance Laboratory, Inc. — Predicate Candidate Screening

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

30 daysmedian FDA review time
40 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K800986TRYPTICASE SOY AGAR W5% SHEEP BLOODQuality Assurance Laboratory, Inc.1980-06-02400
K800987MUELLER HINTON AGARQuality Assurance Laboratory, Inc.1980-06-02400
K800981CHOCOLATE AGAR W/ENRICHMENTSQuality Assurance Laboratory, Inc.1980-05-28350
K800978XYLOSE LYSINE DESOXYCHOLATE AGARQuality Assurance Laboratory, Inc.1980-05-28350
K800982SALMONELLA SHIGELLA AGARQuality Assurance Laboratory, Inc.1980-05-23300
K800985THIOGLYCOLLATE MED. W/O INDICATORQuality Assurance Laboratory, Inc.1980-05-23300
K800980HEXTOEN ENTERIC AGARQuality Assurance Laboratory, Inc.1980-05-23300
K800977THAYER-MARTIN AGARQuality Assurance Laboratory, Inc.1980-05-23300
K800984EOSIN METHYLENE BLUE AGAR, LEVINEQuality Assurance Laboratory, Inc.1980-05-23300
K800979MUELLER HINTIN AGAR W/5% SHEEP BLOODQuality Assurance Laboratory, Inc.1980-05-23300
K800983MACCONKEY AGARQuality Assurance Laboratory, Inc.1980-05-23300

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