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510(k) K943599

CHEM TRAK ACCUMETER by Chemtrak, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
July 6, 1994
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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  • K960478 — ACCUMETER H. PYLORI TEST (June 27, 1996)
  • K943279 — ACCUMETER HDL CHOLESTEROL TEST (May 1, 1995)
  • K914432 — ACCUMETER(R) CHOLESTEROL SELF-TEST (March 2, 1993)
  • K905405 — CHEMTRAK ACCUMETER CHOLESTEROL TEST (March 19, 1991)

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