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510(k) K822118

FERMCOTEST CREATININE TEST REAGENT by Fermco Biochemics, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1982
Date Received
July 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Fermco Biochemics, Inc.

  • K843832 — TRIGLYCERIDES REAGENT SYSTEM (November 27, 1984)
  • K823106 — RERMCO TEST CHLORIDE REAGENT (November 16, 1982)
  • K822117 — FERMCOTEST CO2 REAGNET (September 30, 1982)
  • K810567 — GERMCO TEST R GLUCOSE TEST KIT (March 13, 1981)
  • K791066 — GLUCOSE GOD-PAP TRINDER METHOD TEST KIT (September 4, 1979)
  • K791018 — FERMCOTEST R BUN RATE REAGENT TEST KIT (July 17, 1979)
  • K781945 — GLUCOSE OXIDASE REAGENT (January 17, 1979)

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