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510(k) K141289

TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS by Teco Diagnostics — Product Code JIL

K141289 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS". The FDA issued a decision of Substantially Equivalent on July 24, 2015. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Teco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2015
Date Received
May 19, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Teco Diagnostics

  • 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)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • 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 JIL

  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K183432 — cobas u 601 urinalysis test system (May 7, 2019)
  • K173327 — DIP/U.S. Urine Analysis Test System (July 18, 2018)
  • K180356 — inui In-Home Urine Analysis Test System (May 25, 2018)
  • K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (May 23, 2018)
  • K171521 — DUS R-50S (Urine Chemistry system) (February 16, 2018)
  • K171083 — iChemVELOCITY Automated Urine Chemistry System (May 12, 2017)
  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (May 29, 2014)

FDA data resources