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510(k) K875049

MD STRIPS BG by Amatech International, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1988
Date Received
December 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Amatech International, Inc.

  • K872704 — AMASTIM 2000 (January 22, 1988)
  • K862806 — URINE DIAGNOSTIC REAGENT STRIPS (December 4, 1986)

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