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510(k) K131236

UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP by Ucp Biosciences, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2013
Date Received
May 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Ucp Biosciences, Inc.

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  • K131811 — UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS (July 19, 2013)
  • K130463 — UCP HOME DRUG SCREENING TEST; CARDS, CUPS (May 15, 2013)
  • K123863 — UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS (January 9, 2013)
  • K122419 — UCP HOME DRUG SCREENING TEST CUPS (November 30, 2012)
  • K110515 — UCP DRUG SCREENING TEST CUPS (April 20, 2011)
  • K091612 — UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; (February 24, 2010)
  • K091588 — UCP HOME DRUG SCREENING TESTS (September 4, 2009)

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