Home / 510(k) Clearances / K921495

510(k) K921495

DIA STRIPS SYSTEM, MODIFIED by Symcon Intl., Inc. — Product Code JIO

K921495 is an FDA 510(k) premarket notification submitted by Symcon Intl., Inc. for the device "DIA STRIPS SYSTEM, MODIFIED". The FDA issued a decision of Substantially Equivalent on July 21, 1992. 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
July 21, 1992
Date Received
March 6, 1992
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)
  • K083724 — WIENER LAB. URINE STRIP 10 AND 11 (September 2, 2009)
  • K040703 — URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS (August 26, 2004)
  • K023297 — URS-1B (BLOOD TEST) (March 6, 2003)
  • 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