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510(k) K141410

ORAGENE DX OGD-500.001 by DNA Genotek, Inc. — Product Code OYJ

K141410 is an FDA 510(k) premarket notification submitted by DNA Genotek, Inc. for the device "ORAGENE DX OGD-500.001". The FDA issued a decision of Substantially Equivalent on February 19, 2015. The device falls under product code OYJ (Dna Specimen Collection, Saliva), a Class II device regulated under 21 CFR 862.1675. DNA Genotek, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2015
Date Received
May 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Specimen Collection, Saliva
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.

Other clearances by DNA Genotek, Inc.

  • K254121 — Colli-Pee•Dx Urine Collection Kit (June 10, 2026)
  • K212745 — ORAcollect®•Dx (October 27, 2022)
  • 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)
  • K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 (December 2, 2011)

Other clearances for product code OYJ

  • K212745 — ORAcollect®•Dx (October 27, 2022)
  • K192947 — AncestryDNA Saliva Collection Kit (August 13, 2020)
  • K192920 — Oragene®•Dx (January 14, 2020)
  • K152464 — ORAcollect.Dx (May 26, 2016)
  • K152556 — Oragene Dx (May 26, 2016)
  • K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 (December 2, 2011)

FDA data resources