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510(k) K083724

WIENER LAB. URINE STRIP 10 AND 11 by Wiener Laboratorios Saic — Product Code JIO

K083724 is an FDA 510(k) premarket notification submitted by Wiener Laboratorios Saic for the device "WIENER LAB. URINE STRIP 10 AND 11". The FDA issued a decision of Substantially Equivalent on September 2, 2009. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2009
Date Received
December 15, 2008
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 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)
  • K040703 — URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS (August 26, 2004)
  • K023297 — URS-1B (BLOOD TEST) (March 6, 2003)
  • 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