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510(k) K071100

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

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

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  • 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)