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510(k) K811193

BUN RATE REAGENT by Chem-Elec, Inc. — Product Code CDS

K811193 is an FDA 510(k) premarket notification submitted by Chem-Elec, Inc. for the device "BUN RATE REAGENT". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code CDS (Electrode, Ion Specific, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Chem-Elec, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
April 30, 1981
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 Chem-Elec, Inc.

  • K943503 — CHEMCARD GLUCOSE TEST (July 23, 1996)
  • K864159 — SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (June 10, 1988)
  • K811319 — CHLORIDE REAGENT KIT (August 13, 1981)
  • K811381 — ASTRA (August 13, 1981)
  • K811406 — CREATININE RATE REAGENT KIT (August 13, 1981)
  • K811165 — GLUCOSE OXIDASE RATE REAGENT (August 13, 1981)
  • K811310 — SODIUM/POTASSIUM REAGENT KITS (July 10, 1981)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)

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)
  • K800616 — BUN REAGENT KIT #88108 (April 10, 1980)
  • K800590 — BUN KIT (April 4, 1980)
  • K800071 — BUN REAGENT KIT (February 5, 1980)

FDA data resources