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510(k) K061944

POLY-CHEM CREATININE by Polymedco, Inc. — Product Code JFY

K061944 is an FDA 510(k) premarket notification submitted by Polymedco, Inc. for the device "POLY-CHEM CREATININE". The FDA issued a decision of Substantially Equivalent on November 3, 2006. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Polymedco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2006
Date Received
July 10, 2006
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 Polymedco, Inc.

  • K112408 — POLY-CHEM 90 ISE MODULE (November 4, 2011)
  • K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI (September 8, 2011)
  • K111143 — POLY-CHEM 90 TOTAL BILIRUBIN (September 1, 2011)
  • K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-C (September 28, 2010)
  • K090703 — POLY-CHEM 90 GLUCOSE (October 20, 2009)
  • K053553 — NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (March 9, 2006)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)
  • K041297 — POLYMEDCO OC LIGHT FOBT TEST (August 12, 2004)
  • K033706 — POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS (February 4, 2004)
  • K023654 — GLYCA-DIRECT FRUCTOSAMINE (May 2, 2003)

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