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

Roche Analytical Instruments, Inc. — Predicate Candidate Screening

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

30 daysmedian FDA review time
39 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K801299COBAS CK-NAC REAGENTRoche Analytical Instruments, Inc.1980-07-14420
K801298COBAS REAGENT FOR TRIGLYCERIDES & COBASRoche Analytical Instruments, Inc.1980-07-08360
K801295COBAS REAGENT FOR A-AMYLASERoche Analytical Instruments, Inc.1980-07-08360
K801296COBAS REAGENT FOR CHOLESTEROLRoche Analytical Instruments, Inc.1980-06-30280
K801297COBAS REAGENT FOR GLUCOSE RAPIDRoche Analytical Instruments, Inc.1980-06-30280
K801243COBAS REAGENTS FOR URIC ACIDRoche Analytical Instruments, Inc.1980-06-26300
K801118COBAS REAGENT FOR AST (SGOT)Roche Analytical Instruments, Inc.1980-06-20390
K801242COBAS REAGENT FOR ALKALINE PHOSPHATASERoche Analytical Instruments, Inc.1980-06-20240
K801116COBAS REAGENT FOR BUNRoche Analytical Instruments, Inc.1980-06-17360
K801119COBAS REAGENT FOR ALT (GPT)Roche Analytical Instruments, Inc.1980-06-09280
K801117COBAS TOTAL BILIRUBIN REAGENT & DILUENTRoche Analytical Instruments, Inc.1980-06-09280

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