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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

K131236 is an FDA 510(k) premarket notification submitted by Ucp Biosciences, Inc. for the device "UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP". The FDA issued a decision of Substantially Equivalent on November 7, 2013. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Ucp Biosciences, Inc. has at least 10 other 510(k) clearances on record.

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.

  • 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)
  • 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)

Other clearances for product code LCX

  • K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P (September 9, 2025)
  • K251053 — Shinetell PlusTM Digital Early Pregnancy Test (July 15, 2025)
  • K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (February 13, 2025)
  • K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synth (January 31, 2025)
  • K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Casse (January 15, 2025)
  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
  • K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test (October 11, 2024)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc (June 21, 2024)
  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)

FDA data resources