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510(k) K152464

ORAcollect.Dx by DNA Genotek, Inc. — Product Code OYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2016
Date Received
August 31, 2015
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.

  • K212745 — ORAcollect®•Dx (October 27, 2022)
  • DEN200040 — OMNIgene GUT Dx (November 3, 2021)
  • K192920 — Oragene®•Dx (January 14, 2020)
  • 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)

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)
  • 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)