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510(k) K080073

S-TEST CREATININE (CRE) by Alfa Wassermann, Inc. — Product Code JFY

K080073 is an FDA 510(k) premarket notification submitted by Alfa Wassermann, Inc. for the device "S-TEST CREATININE (CRE)". The FDA issued a decision of Substantially Equivalent on June 30, 2008. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Alfa Wassermann, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2008
Date Received
January 11, 2008
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 Alfa Wassermann, Inc.

  • K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (August 14, 2013)
  • K113382 — ACE ALT REAGENT (July 19, 2012)
  • K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (July 12, 2012)
  • K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILI (July 2, 2012)
  • K091413 — S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC00 (October 26, 2009)
  • K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (September 9, 2009)
  • K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (August 3, 2009)
  • K063306 — ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-7 (April 17, 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