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510(k) K071580

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL by Thermofisher Scientific OY — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2007
Date Received
June 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type

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  • K073191 — ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL (February 28, 2008)
  • K070824 — CREATININE (ENZYMATIC) (December 3, 2007)
  • K071340 — CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL (October 5, 2007)

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