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510(k) K791018

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

K791018 is an FDA 510(k) premarket notification submitted by Fermco Biochemics, Inc. for the device "FERMCOTEST R BUN RATE REAGENT TEST KIT". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code CDS (Electrode, Ion Specific, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Fermco Biochemics, Inc. has at least 7 other 510(k) clearances on record.

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.

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

Other clearances for product code CDS

  • K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (January 17, 2018)
  • K040973 — BUN REAGENT (December 27, 2004)
  • K033056 — BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT (January 30, 2004)
  • K925550 — HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (April 20, 1993)
  • K860543 — BLOOD UREA NITROGEN (BUN) TESTCARD (April 21, 1986)
  • K855091 — CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS (March 14, 1986)
  • K812308 — LANCER BUN RATE REAGENT KIT (August 31, 1981)
  • K811193 — BUN RATE REAGENT (July 10, 1981)
  • K800616 — BUN REAGENT KIT #88108 (April 10, 1980)
  • K800590 — BUN KIT (April 4, 1980)

FDA data resources