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510(k) K961123

ALT INCORPORATING DST by Trace Scientific , Ltd. — Product Code CKA

K961123 is an FDA 510(k) premarket notification submitted by Trace Scientific , Ltd. for the device "ALT INCORPORATING DST". The FDA issued a decision of Substantially Equivalent on April 25, 1996. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Trace Scientific , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1996
Date Received
March 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Trace Scientific , Ltd.

  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K981123 — UREA (April 24, 1998)
  • K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (September 27, 1996)
  • K961114 — AST INCORPORATING DST (May 23, 1996)
  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)
  • K903897 — TRIGLYCERIDES REAGENT GPO 5 X CONC. (October 1, 1990)

Other clearances for product code CKA

  • K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZE (June 7, 2013)
  • K113382 — ACE ALT REAGENT (July 19, 2012)
  • K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARB (May 10, 2006)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • 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)
  • K974003 — ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (December 5, 1997)
  • K971323 — ALT OR SGPT (April 21, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K952427 — CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHO (September 21, 1995)

FDA data resources