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510(k) K080485

ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS by Diasys Diagnostics Systems GmbH — Product Code CIT

K080485 is an FDA 510(k) premarket notification submitted by Diasys Diagnostics Systems GmbH for the device "ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS". The FDA issued a decision of Substantially Equivalent on December 4, 2008. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2008
Date Received
February 22, 2008
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

Other clearances for product code CIT

  • K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250 (September 20, 2010)
  • K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE (March 19, 2008)
  • K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (October 3, 2007)
  • K071211 — COBAS C 111 ANALYZER (July 30, 2007)
  • K060318 — HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (August 8, 2006)
  • K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA (December 9, 2002)
  • K013698 — AST (SGOT) (December 21, 2001)
  • K013145 — WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML (November 27, 2001)
  • K010488 — ATAC PAK AST REAGENT KIT (April 9, 2001)
  • K001679 — VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 (June 28, 2000)

FDA data resources