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510(k) K040973

BUN REAGENT by Genchem, Inc. — Product Code CDS

K040973 is an FDA 510(k) premarket notification submitted by Genchem, Inc. for the device "BUN REAGENT". The FDA issued a decision of Substantially Equivalent on December 27, 2004. The device falls under product code CDS (Electrode, Ion Specific, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Genchem, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2004
Date Received
April 14, 2004
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 Genchem, Inc.

  • K090283 — CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 (June 5, 2009)
  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • K040977 — GENCHEM ELECTROLYTE BUFFER (December 27, 2004)
  • K040972 — CALCIUM, AZO DYE REAGENT (December 27, 2004)
  • K040976 — GENCHEM CREATININE REAGENT (December 27, 2004)
  • K040974 — GLUCOSE OXIDASE, GLUCOSE (December 27, 2004)
  • K040971 — GENCHEM ISE ELECTROLYTE REFERENCE (December 22, 2004)

Other clearances for product code CDS

  • K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (January 17, 2018)
  • 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)
  • K800071 — BUN REAGENT KIT (February 5, 1980)

FDA data resources