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510(k) K822117

FERMCOTEST CO2 REAGNET by Fermco Biochemics, Inc. — Product Code JFL

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
Ph Rate Measurement, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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  • 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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