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510(k) K024182

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS by Precision Systems, Inc. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2003
Date Received
December 19, 2002
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 Precision Systems, Inc.

  • K022072 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENT (August 23, 2002)
  • K013654 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (June 5, 2002)

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)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K012649 — RAICHEM BUN RATE REAGENT (October 15, 2001)
  • K012260 — WIENER LAB. UREA UV CINETICA AA (September 19, 2001)