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510(k) K091588

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

K091588 is an FDA 510(k) premarket notification submitted by Ucp Biosciences, Inc. for the device "UCP HOME DRUG SCREENING TESTS". The FDA issued a decision of Substantially Equivalent on September 4, 2009. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Ucp Biosciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2009
Date Received
June 2, 2009
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.

  • 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)
  • K091612 — UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; (February 24, 2010)

Other clearances for product code DKZ

  • K240670 — DRI Ecstasy Plus Assay (October 30, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (May 19, 2023)
  • K200363 — Quidel Triage® TOX Drug Screen, 94600 (March 11, 2020)
  • K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (October 3, 2019)
  • K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (June 19, 2019)
  • K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul (March 27, 2019)
  • K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- (December 14, 2018)
  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)

FDA data resources