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510(k) K052719

URITEST 10 URINALYSIS REAGENT STRIPS by Arj Medical, Inc. — Product Code CDM

K052719 is an FDA 510(k) premarket notification submitted by Arj Medical, Inc. for the device "URITEST 10 URINALYSIS REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on December 5, 2006. The device falls under product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1785. Arj Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2006
Date Received
September 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1785
Review Panel
CH
Submission Type

Other clearances by Arj Medical, Inc.

  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K052708 — PYLO-PLUS (May 1, 2006)

Other clearances for product code CDM

  • K061559 — ACON URINALYSIS REAGENT STRIPS (August 11, 2006)
  • K880584 — URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (May 31, 1988)
  • K873366 — WAKO(TM) PRETEST 5A (January 21, 1988)
  • K852611 — TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (September 3, 1985)
  • K821799 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K830340 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)
  • K790965 — REAGENT STRIPS FOR URINALYSIS (June 28, 1979)

FDA data resources