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510(k) K062737

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER by Horiba Abx — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2007
Date Received
September 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K083465 — DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREAT (February 27, 2009)
  • K081731 — DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND (August 29, 2008)
  • K072548 — CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (April 18, 2008)
  • K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (January 31, 2006)
  • K043202 — OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 (December 23, 2004)