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510(k) K073612

URIC ACID (AOX), SCAL, NORTROL, ABTROL by Thermofisher Scientific OY — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2008
Date Received
December 21, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Thermofisher Scientific OY

  • K110035 — INDIKO (June 28, 2011)
  • K073295 — UREA/BUN, SCAL, NORTROL, ABTROL (May 29, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K073191 — ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, 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)

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