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

Caltag Laboratories, Inc. — Predicate Candidate Screening

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

295 daysmedian FDA review time
301 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990641CALTAG FETAL HEMOGLOBIN TESTCaltag Laboratories, Inc.1999-09-172030
K965232CALTAG CAL-LYSECaltag Laboratories, Inc.1997-05-141340
K964856CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINCaltag Laboratories, Inc.1997-01-17440
K963954CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODYCaltag Laboratories, Inc.1996-11-25540
K950916CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.1995-12-212950
K950918CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATIONCaltag Laboratories, Inc.1995-12-212950
K950917CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINACaltag Laboratories, Inc.1995-12-212950
K951073CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATCaltag Laboratories, Inc.1995-12-212880
K950919CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINACaltag Laboratories, Inc.1995-12-202940
K944126CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIESCaltag Laboratories, Inc.1995-06-203010
K944128CALTAG CD4 R-PE MONOCLONAL ANTIBODYCaltag Laboratories, Inc.1995-06-203010
K944127CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODYCaltag Laboratories, Inc.1995-06-203010

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