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510(k) K925550

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 by Hichem Diagnostics — Product Code CDS

K925550 is an FDA 510(k) premarket notification submitted by Hichem Diagnostics for the device "HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code CDS (Electrode, Ion Specific, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Hichem Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
November 3, 1992
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 Hichem Diagnostics

  • K981794 — HICHEM CALCIUM REAGENT KIT (July 29, 1998)
  • K963383 — HICHEM ALP/AMP REAGENT KIT (September 23, 1996)
  • K953863 — HICHEM ISE STANDARDS KIT 70011 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (September 6, 1995)
  • K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009 (September 6, 1995)
  • K951751 — HICHEM AST REAGENT KIT (August 2, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)
  • K941433 — HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (August 2, 1994)

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)
  • 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