Home / 510(k) Clearances / K232317

510(k) K232317

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips by Urit Medical Electronic Co., Ltd. — Product Code JIO

K232317 is an FDA 510(k) premarket notification submitted by Urit Medical Electronic Co., Ltd. for the device "UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips". The FDA issued a decision of Substantially Equivalent on April 26, 2024. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550. Urit Medical Electronic Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2024
Date Received
August 3, 2023
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 Urit Medical Electronic Co., Ltd.

  • K082811 — URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANA (September 11, 2009)

Other clearances for product code JIO

  • 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)
  • 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