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

Coulter Immunology · Predicate Candidate Screening

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

157 daysmedian FDA review time
281 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922744CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1Coulter Immunology1993-02-052420
K922745CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1Coulter Immunology1993-02-052420
K910473CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITCCoulter Immunology1991-10-312690
K911793COULTERCLONECoulter Immunology1991-07-09780
K893852COULTER CLONE T4 MONOCLONAL ANTIBODYCoulter Immunology1990-03-022810
K893853COULTER CLONE T8 MONOCLONAL ANTIBODYCoulter Immunology1990-03-022810
K894179COULTER CLONE(R) MY4 MONOCLONAL ANTIBODYCoulter Immunology1990-02-122410
K895917CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTICoulter Immunology1989-12-29800
K884605COULTER CLONE MO2Coulter Immunology1989-08-152850
K893419COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)Coulter Immunology1989-08-03930
K883710COULTER CLONE T3 MONOCLONAL ANTIBODYCoulter Immunology1989-02-031570
K884020COULTER CLONE B4 MONOCLONAL ANTIBODYCoulter Immunology1989-02-031340
K883753COULTER CLONE T1 MONOCLONAL ANTIBODYCoulter Immunology1989-02-031540
K884346CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTICoulter Immunology1988-12-27740
K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter Immunology1988-11-30790
K882557COULTER CLONE B1 MONOCLONAL ANTIBODYCoulter Immunology1988-09-14850

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