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510(k) K934533

BUN-300/BUN-500 UREA NITROGEN REAGENT by Horizon Diagnostics, Inc. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1993
Date Received
September 17, 1993
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 Horizon Diagnostics, Inc.

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  • K933722 — HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (June 13, 1996)
  • K935712 — IRON/TIBC REAGENT (September 20, 1995)
  • K930678 — AMYLASE (April 6, 1994)
  • K930679 — DIRECT BILIRUBIN (June 29, 1993)
  • K930074 — IN-VITRO DIAGNOSTIC REAGENT SET (May 11, 1993)

Other clearances for product code CDQ

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  • 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)