FDA 510(k)

ORAcollect®•Dx

K-Number: K212745 · 2022-10-27

Decision Date2022-10-27

Product CodeOYJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ORAcollect®•Dx is the device name listed in this FDA 510(k) record. The listed applicant is DNA Genotek, Inc.. It received FDA 510(k) clearance on 2022-10-27 under 510(k) number K212745. The device is classified under product code OYJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAcollect®•Dx?

ORAcollect®•Dx is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is DNA Genotek, Inc.. The 510(k) number is K212745.

When did ORAcollect®•Dx receive FDA 510(k) clearance?

ORAcollect®•Dx received FDA 510(k) clearance on 2022-10-27, under 510(k) number K212745.

Who is the listed applicant for ORAcollect®•Dx?

The FDA 510(k) record lists DNA Genotek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAcollect®•Dx?

The FDA product code for ORAcollect®•Dx is OYJ.

Other records listing DNA Genotek, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254121Colli-Pee•Dx Urine Collection Kit K192920Oragene®•Dx K152556Oragene Dx K152464ORAcollect.Dx

Related Devices (Code: OYJ)

K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc.K192920Oragene®•DxDNA Genotek, Inc.K152556Oragene DxDNA Genotek, Inc.K152464ORAcollect.DxDNA Genotek, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.