Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Chimera Research & Chemical, Inc. · Predicate Candidate Screening

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

132 daysmedian FDA review time
403 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970087CR PERFECTChimera Research & Chemical, Inc.1997-03-06550
K951877AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINEChimera Research & Chemical, Inc.1996-05-144030
K953393TOX PERFECT A TUBEChimera Research & Chemical, Inc.1995-10-06840
K952501TOX PERFECT B TUBES AND REAGENTSChimera Research & Chemical, Inc.1995-08-24860
K950142CR PERFECTChimera Research & Chemical, Inc.1995-05-251320
K940768AD PERFECTChimera Research & Chemical, Inc.1995-02-173640
K935408UA PERFECTChimera Research & Chemical, Inc.1994-06-132160

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