ClearanceBrief
510(k) K010765 ยท GKZ Counter, Differential Cell

COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526

ApplicantBeckman Coulter, Inc., Miami FL, US
DecisionSubstantially Equivalent, Apr 13, 2001
ReceivedMar 14, 2001
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K010765

DateFirm and productCodeLinked 510(k)
Jun 26, 2017Beckman Coulter Inc.
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs addit
Terminated		 GKZNone listed
Jan 11, 2012Beckman Coulter Inc.
Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is
Terminated		 GKZNone listed
Jan 11, 2012Beckman Coulter Inc.
Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematol
Terminated		 GKZNone listed
Apr 20, 2011Beckman Coulter Inc.
COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter fo
Terminated		 GKZNone listed
Apr 20, 2011Beckman Coulter Inc.
COULTER HmX Hematology Analyzer with Autoloader Part number: 6605525, 6605526, 6605527 The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential
Terminated		 GKZNone listed
Mar 18, 2011Beckman Coulter Inc.
Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564. Quantitative
Terminated		 GKZNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.