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510(k) K791018

FERMCOTEST R BUN RATE REAGENT TEST KIT by Fermco Biochemics, Inc. — Product Code CDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1979
Date Received
June 1, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Fermco Biochemics, Inc.

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  • K822118 — FERMCOTEST CREATININE TEST REAGENT (September 30, 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)
  • K781945 — GLUCOSE OXIDASE REAGENT (January 17, 1979)

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  • K800616 — BUN REAGENT KIT #88108 (April 10, 1980)
  • K800590 — BUN KIT (April 4, 1980)