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510(k) K980030

AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) by Trace America, Inc. — Product Code CIT

K980030 is an FDA 510(k) premarket notification submitted by Trace America, Inc. for the device "AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)". The FDA issued a decision of Substantially Equivalent on January 30, 1998. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Trace America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
January 5, 1998
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 Trace America, Inc.

  • K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (January 17, 2001)
  • K980026 — GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (March 10, 1998)
  • K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (February 2, 1998)
  • K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA (January 7, 1998)
  • K974620 — AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (January 2, 1998)
  • K972297 — AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (July 17, 1997)
  • K971485 — URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (May 27, 1997)
  • K971477 — UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (May 27, 1997)
  • K962723 — TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN (March 13, 1997)
  • K961984 — PORPHOBILINOGEN (PBG) (December 10, 1996)

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