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510(k) K070727

ADVIA CHEMISTRY ENZYMATIC CREATININE_2 by Siemens Medical Solutions Diagnostics — Product Code JFY

K070727 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "ADVIA CHEMISTRY ENZYMATIC CREATININE_2". The FDA issued a decision of Substantially Equivalent on August 3, 2007. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2007
Date Received
March 15, 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

Other clearances by Siemens Medical Solutions Diagnostics

  • K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (May 11, 2011)
  • K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (October 28, 2009)
  • K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (January 8, 2009)
  • K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (September 11, 2008)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (April 1, 2008)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)
  • K071466 — DCA VANTAGE, MODEL 5075 (October 9, 2007)
  • K072204 — ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (October 5, 2007)
  • K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 (May 2, 2007)

Other clearances for product code JFY

  • K252619 — QSCHECK UISACR (February 20, 2026)
  • K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3) (November 24, 2021)
  • 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)

FDA data resources