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510(k) K071100

AMNISCREEN HOME DETECTION LINER KIT by Common Sense , Ltd. — Product Code CEN

K071100 is an FDA 510(k) premarket notification submitted by Common Sense , Ltd. for the device "AMNISCREEN HOME DETECTION LINER KIT". The FDA issued a decision of Substantially Equivalent on October 15, 2007. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550. Common Sense , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2007
Date Received
April 19, 2007
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 by Common Sense , Ltd.

  • K091287 — VS-SENSE TEST (August 31, 2009)

Other clearances for product code CEN

  • K091287 — VS-SENSE TEST (August 31, 2009)
  • K051727 — AIMSTICK URINE REAGENT STRIPS (October 26, 2005)
  • K040008 — QUICKVUE ADVANCE PH AND AMINES GLL TEST (April 29, 2004)
  • K030650 — STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (April 14, 2003)
  • 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