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510(k) K800071

BUN REAGENT KIT by Fisher Scientific Co., LLC — Product Code CDS

K800071 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "BUN REAGENT KIT". The FDA issued a decision of Substantially Equivalent on February 5, 1980. The device falls under product code CDS (Electrode, Ion Specific, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1980
Date Received
January 11, 1980
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 Fisher Scientific Co., LLC

  • K930415 — MICROHEMATOCRIT ROTOR (March 23, 1993)
  • K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (March 11, 1992)
  • K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (January 8, 1992)
  • K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (March 8, 1989)
  • K881275 — URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II (May 16, 1988)
  • K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (October 20, 1987)
  • K872916 — HISTOMATIC SLIDE STAINER, CODE-ON VERSION (September 14, 1987)
  • K871058 — SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) (April 6, 1987)
  • K863224 — HEMATALL-C PLUS HEMATOLOGY CONTROLS (October 29, 1986)
  • K862318 — FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR (July 10, 1986)

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