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510(k) K780505

SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE by Gamma Enterprises, Inc. — Product Code CIT

K780505 is an FDA 510(k) premarket notification submitted by Gamma Enterprises, Inc. for the device "SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Gamma Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
March 30, 1978
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 by Gamma Enterprises, Inc.

  • K790578 — GAMMA SMAC REAGENTS (May 15, 1979)
  • K780504 — CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
  • K771832 — CHLORIDE (November 22, 1977)
  • K771843 — WETTING AGENTS (November 22, 1977)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771834 — CREATININE (November 3, 1977)
  • K771838 — SERUM IRON (November 3, 1977)
  • K771829 — ALKALINE PHOSPHATASE (November 2, 1977)

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)
  • K080485 — ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (December 4, 2008)
  • 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)

FDA data resources