Home / 510(k) Clearances / K941497

510(k) K941497

SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY by Solarcare, Inc. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1994
Date Received
March 28, 1994
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 Solarcare, Inc.

  • K934775 — STC COCAINE METABOLITE EIA (July 14, 1995)
  • K944372 — STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (February 8, 1995)
  • K941496 — SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (October 27, 1994)
  • K934376 — STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA (December 7, 1993)
  • K933327 — HISTOFREEZER (October 29, 1993)

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)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)