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510(k) K091612

UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; by Ucp Biosciences, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2010
Date Received
June 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Ucp Biosciences, Inc.

  • K152908 — UCP COMPACT DRUG TESTS (May 3, 2016)
  • 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)
  • K091588 — UCP HOME DRUG SCREENING TESTS (September 4, 2009)

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