Home / 510(k) Clearances / K943436

510(k) K943436

URINE REAGENT STRIPS-8 PARAMETERS by Teco Diagnostics — Product Code JJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1995
Date Received
July 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1115
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)
  • 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)

Other clearances for product code JJB

  • K943008 — BIOSCAN REAGENT STRIPS (August 8, 1994)
  • K873553 — WAKO(TM) PRETEST 8A (September 22, 1987)
  • K862806 — URINE DIAGNOSTIC REAGENT STRIPS (December 4, 1986)
  • K833521 — REAGENT TESTS STRIP COMBINATIONS (January 11, 1984)