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510(k) K152908

UCP COMPACT DRUG TESTS by Ucp Biosciences, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2016
Date Received
October 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Ucp Biosciences, Inc.

  • K151213 — UCP Drug Test Mini Cups (August 21, 2015)
  • K132812 — UCP MULTI-DRUG TEST KEY CUPS (March 6, 2014)
  • K131236 — UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDS (November 7, 2013)
  • 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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