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510(k) K914432

ACCUMETER(R) CHOLESTEROL SELF-TEST by Chemtrak, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1993
Date Received
October 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

Other clearances by Chemtrak, Inc.

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  • K965099 — ACCUMETER H. PYLORI TEST (February 20, 1997)
  • K960478 — ACCUMETER H. PYLORI TEST (June 27, 1996)
  • K943279 — ACCUMETER HDL CHOLESTEROL TEST (May 1, 1995)
  • K943599 — CHEM TRAK ACCUMETER (March 21, 1995)
  • K905405 — CHEMTRAK ACCUMETER CHOLESTEROL TEST (March 19, 1991)

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