Home / 510(k) Clearances / K871547

510(k) K871547

ULTRA-VIOLET BUN REAGENT KIT (RATE) by Biochemical Trade, Inc. — Product Code CDQ

K871547 is an FDA 510(k) premarket notification submitted by Biochemical Trade, Inc. for the device "ULTRA-VIOLET BUN REAGENT KIT (RATE)". The FDA issued a decision of Substantially Equivalent on June 22, 1987. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Biochemical Trade, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1987
Date Received
April 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Biochemical Trade, Inc.

  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K910635 — TOTAL BILIRUBIN REAGENT SET (May 15, 1991)
  • K910296 — PHOSPHORUS (INORGANIC) TEST SYSTEM (February 27, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)
  • K905790 — TOTAL PROTEIN REAGENT SET (February 21, 1991)
  • K905619 — CREATININE (RATE) REAGENT SET (February 13, 1991)
  • K905650 — KINETIC ALKALINE PHOSPHATASE DETERMINATION (February 13, 1991)
  • K905651 — KINETIC AMYLASE DETERMINATION (January 31, 1991)
  • K905649 — GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (January 30, 1991)
  • K905588 — CREATINE KINASE UV REAGENT SET (January 17, 1991)

Other clearances for product code CDQ

  • K203771 — Urea Nitrogen2 (May 31, 2022)
  • K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER (September 2, 2014)
  • K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS (April 21, 2011)
  • K073295 — UREA/BUN, SCAL, NORTROL, ABTROL (May 29, 2008)
  • K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP (October 12, 2007)
  • K060120 — TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM (March 27, 2006)
  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K024182 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (March 3, 2003)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K012649 — RAICHEM BUN RATE REAGENT (October 15, 2001)

FDA data resources