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510(k) K932727

CHOLESTECH L.D.X. SYSTEM by Cholestech Corp. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1993
Date Received
June 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Cholestech Corp.

  • K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (June 18, 2004)
  • K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (September 5, 2003)
  • 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)

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