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510(k) K770457

CHOLESTEROL PROCEDURE, TEKPOINT TOTAL by Icn Pharmaceuticals, Inc. — Product Code CGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1977
Date Received
March 8, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

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Other clearances for product code CGO

  • K850938 — CHOLESTEROL (June 25, 1985)
  • K811747 — KING DIAGNOSTICS CHOLESTEROL TEST (July 10, 1981)
  • K810090 — CHOLESTEROL REAGENT (January 26, 1981)
  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)
  • K781611 — CHOLESTEROL DET. IN SERUM (October 24, 1978)
  • K780545 — SR-PLUS DIRECT CHOLESTEROL TEST (May 26, 1978)
  • K772043 — ALPHA/CHOL (November 28, 1977)
  • K771833 — CHOLESTEROL (October 18, 1977)
  • K771313 — CHOLESTEROL REAGENT (August 3, 1977)
  • K771093 — UNIPAK CHOLESTEROL (July 21, 1977)