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510(k) K791066

GLUCOSE GOD-PAP TRINDER METHOD TEST KIT by Fermco Biochemics, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1979
Date Received
June 12, 1979
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 Fermco Biochemics, Inc.

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  • K822117 — FERMCOTEST CO2 REAGNET (September 30, 1982)
  • K822118 — FERMCOTEST CREATININE TEST REAGENT (September 30, 1982)
  • K810567 — GERMCO TEST R GLUCOSE TEST KIT (March 13, 1981)
  • K791018 — FERMCOTEST R BUN RATE REAGENT TEST KIT (July 17, 1979)
  • K781945 — GLUCOSE OXIDASE REAGENT (January 17, 1979)

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