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510(k) K070824

CREATININE (ENZYMATIC) by Thermofisher Scientific OY — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2007
Date Received
March 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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  • 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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  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbu (December 22, 2014)