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510(k) K030650

STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS by Uridynamics, Inc. — Product Code CEN

K030650 is an FDA 510(k) premarket notification submitted by Uridynamics, Inc. for the device "STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS". The FDA issued a decision of Substantially Equivalent on April 14, 2003. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2003
Date Received
February 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

Other clearances for product code CEN

  • K091287 — VS-SENSE TEST (August 31, 2009)
  • K071100 — AMNISCREEN HOME DETECTION LINER KIT (October 15, 2007)
  • K051727 — AIMSTICK URINE REAGENT STRIPS (October 26, 2005)
  • K040008 — QUICKVUE ADVANCE PH AND AMINES GLL TEST (April 29, 2004)
  • K962718 — FEMEXAM TESTCARD (February 7, 1997)
  • K840827 — KYOTEST 5V (May 14, 1984)
  • K830824 — URINE SCREENING KIT (June 12, 1983)
  • K830979 — HELENA BIOSTRIP PH (May 5, 1983)
  • K830091 — LITH A TEST TM (February 15, 1983)
  • K822241 — FOLATE/B12 DUO-BEAD RADIOASSAY (October 26, 1982)

FDA data resources