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510(k) K894173

BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT by Catachem, Inc. — Product Code CDQ

K894173 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Catachem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
June 15, 1989
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 Catachem, Inc.

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K903341 — MAGNESIUM (August 22, 1990)
  • K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS (July 31, 1990)
  • K902877 — TOTAL IRON FOR MANUAL/AUTOMATED (July 27, 1990)
  • K895748 — BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (December 21, 1989)
  • K895821 — URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (December 5, 1989)
  • K894715 — CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS (November 8, 1989)
  • K894476 — CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (October 12, 1989)

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