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510(k) K823106

RERMCO TEST CHLORIDE REAGENT by Fermco Biochemics, Inc. — Product Code JFS

K823106 is an FDA 510(k) premarket notification submitted by Fermco Biochemics, Inc. for the device "RERMCO TEST CHLORIDE REAGENT". The FDA issued a decision of Substantially Equivalent on November 16, 1982. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. Fermco Biochemics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1982
Date Received
October 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coulometric, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

Other clearances by Fermco Biochemics, Inc.

  • K843832 — TRIGLYCERIDES REAGENT SYSTEM (November 27, 1984)
  • 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)
  • K791018 — FERMCOTEST R BUN RATE REAGENT TEST KIT (July 17, 1979)
  • K781945 — GLUCOSE OXIDASE REAGENT (January 17, 1979)

Other clearances for product code JFS

  • K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLOR (March 27, 2013)
  • K923598 — REDI-CHECK PHOTMETER Q.A. (October 14, 1992)
  • K873127 — CHLORIDE REAGENT KIT (October 23, 1987)
  • K830217 — REAGENTS CORNING CHLORIDE METER FOR (February 18, 1983)
  • K820411 — LIQUIZYME CHLORIDE REAGENT (March 8, 1982)
  • K811319 — CHLORIDE REAGENT KIT (August 13, 1981)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K810615 — CORNING 925 CHLORIDE METER (March 17, 1981)
  • K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT (October 10, 1980)

FDA data resources