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510(k) K073634

MULTIGENT CREATININE (ENZYMATIC) ASSAY by SENTINEL CH. SpA — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2008
Date Received
December 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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Other clearances for product code JFY

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  • K193649 — Yumizen C1200 Creatinine PAP (May 10, 2021)
  • K182384 — ACR LAB Urine Analysis Test System (July 26, 2019)
  • K183555 — GEM Premier ChemSTAT (February 16, 2019)
  • K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (December 10, 2018)
  • K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VI (October 30, 2018)
  • 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)