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510(k) K073295

UREA/BUN, SCAL, NORTROL, ABTROL by Thermofisher Scientific OY — Product Code CDQ

K073295 is an FDA 510(k) premarket notification submitted by Thermofisher Scientific OY for the device "UREA/BUN, SCAL, NORTROL, ABTROL". The FDA issued a decision of Substantially Equivalent on May 29, 2008. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Thermofisher Scientific OY has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2008
Date Received
November 23, 2007
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 Thermofisher Scientific OY

  • K110035 — INDIKO (June 28, 2011)
  • K073612 — URIC ACID (AOX), SCAL, NORTROL, ABTROL (May 23, 2008)
  • K073191 — ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL (February 28, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K070824 — CREATININE (ENZYMATIC) (December 3, 2007)
  • K071340 — CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL (October 5, 2007)
  • K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (October 3, 2007)

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)
  • 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)
  • K012260 — WIENER LAB. UREA UV CINETICA AA (September 19, 2001)

FDA data resources