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510(k) K023297

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

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

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  • 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)