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510(k) K254121

Colli-Pee•Dx Urine Collection Kit by DNA Genotek, Inc. — Product Code SIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2026
Date Received
December 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by DNA Genotek, Inc.

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  • DEN200040 — OMNIgene GUT Dx (November 3, 2021)
  • K192920 — Oragene®•Dx (January 14, 2020)
  • K152464 — ORAcollect.Dx (May 26, 2016)
  • K152556 — Oragene Dx (May 26, 2016)
  • K141410 — ORAGENE DX OGD-500.001 (February 19, 2015)
  • K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 (December 2, 2011)