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510(k) K032027

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) by Cholestech Corp. — Product Code CIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2003
Date Received
July 1, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type

Other clearances by Cholestech Corp.

  • K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (June 18, 2004)
  • K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (September 9, 1999)
  • K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM (July 24, 1997)
  • K954778 — CHOLESTECH LDX SYSTEM (November 24, 1995)
  • K946064 — TOTAL CHOLESTEROL CASSETTE (February 22, 1995)
  • K946067 — TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (February 22, 1995)
  • K946065 — TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (February 22, 1995)
  • K946066 — TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (February 22, 1995)
  • K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (February 22, 1995)
  • K932727 — CHOLESTECH L.D.X. SYSTEM (November 9, 1993)

Other clearances for product code CIS

  • K896238 — COBAS READY AST REAGENT (February 16, 1990)
  • K854187 — IN-VITRO TEST DETERMINATION OF SGOT (AST) (November 25, 1985)
  • K812872 — OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (October 26, 1981)
  • K792410 — ELVI SGOT & SGPT TRANSAMINASE (December 6, 1979)