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510(k) K822117

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

K822117 is an FDA 510(k) premarket notification submitted by Fermco Biochemics, Inc. for the device "FERMCOTEST CO2 REAGNET". The FDA issued a decision of Substantially Equivalent on September 30, 1982. The device falls under product code JFL (Ph Rate Measurement, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Fermco Biochemics, Inc. has at least 7 other 510(k) clearances on record.

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

Other clearances by Fermco Biochemics, Inc.

  • K843832 — TRIGLYCERIDES REAGENT SYSTEM (November 27, 1984)
  • K823106 — RERMCO TEST CHLORIDE REAGENT (November 16, 1982)
  • K822118 — FERMCOTEST CREATININE TEST REAGENT (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)

Other clearances for product code JFL

  • K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (December 18, 2001)
  • K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT (October 24, 1996)
  • K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (October 11, 1996)
  • K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (September 27, 1996)
  • K963005 — NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (August 23, 1996)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)

FDA data resources