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510(k) K781611

CHOLESTEROL DET. IN SERUM by Fisher Scientific Co., LLC — Product Code CGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1978
Date Received
September 19, 1978
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

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  • K811747 — KING DIAGNOSTICS CHOLESTEROL TEST (July 10, 1981)
  • K810090 — CHOLESTEROL REAGENT (January 26, 1981)
  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)
  • 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)
  • K770457 — CHOLESTEROL PROCEDURE, TEKPOINT TOTAL (May 3, 1977)