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510(k) K023297

URS-1B (BLOOD TEST) by Teco Diagnostics — Product Code JIO

K023297 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "URS-1B (BLOOD TEST)". The FDA issued a decision of Substantially Equivalent on March 6, 2003. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550. Teco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2003
Date Received
October 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood, Occult, Colorimetric, In Urine
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
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 JIO

  • K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urin (April 26, 2024)
  • K111999 — HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS (April 17, 2012)
  • K111221 — MISSION U500 URINE ANALYZER (January 18, 2012)
  • K082811 — URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANA (September 11, 2009)
  • K083724 — WIENER LAB. URINE STRIP 10 AND 11 (September 2, 2009)
  • K040703 — URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS (August 26, 2004)
  • K921495 — DIA STRIPS SYSTEM, MODIFIED (July 21, 1992)
  • K913005 — BACTIDROP(TM) LACTOPHENOL ANILINE BLUE (September 16, 1991)
  • K905396 — HEMASTIX REAGENT STRIPS (February 11, 1991)
  • K893894 — CHARISE CHARLES REAGENT BLOOD STRIPS (July 27, 1989)

FDA data resources