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510(k) K904784

CHOLESTECH L.D.X. LEVEL 1 CONTROL by Cholestech Corp. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
October 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Cholestech Corp.

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  • 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)
  • K946066 — TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (February 22, 1995)
  • K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (February 22, 1995)
  • K946065 — TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (February 22, 1995)
  • K946067 — TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (February 22, 1995)

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  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)