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510(k) K152835

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM by Teco Diagnostics, Inc. — Product Code JFY

K152835 is an FDA 510(k) premarket notification submitted by Teco Diagnostics, Inc. for the device "URITEK TC-201 URINE CHEMISTRY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 2016. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Teco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2016
Date Received
September 29, 2015
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 Teco Diagnostics, Inc.

  • K170118 — Scanostics UTI Check Application Test System (September 21, 2017)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
  • K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (May 29, 2014)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 2011)
  • K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS (February 17, 2011)
  • K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (February 4, 2011)
  • K073370 — TC MATRIX CLINICAL CHEMISTRY ANALYZER (May 8, 2008)

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)
  • K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbu (December 22, 2014)
  • K132399 — ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, (January 3, 2014)

FDA data resources