ORAcollect.Dx— 510(k) K152464

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K152464 for ORAcollect.Dx, Substantially Equivalent on 2016-05-26. Applicant: DNA Genotek, Inc.. Device class: 2.

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code OYJ
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2015-08-31
Decision date: 2016-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code OYJ

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K152556 — Oragene Dx2016-05-26
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Recalls naming K152464

K-number listed on FDA's recall record

Z-0981-2022 — ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025Class II·Ongoing·DNA Genotek Inc.·20220218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152464.

Data sourced from openFDA. This site is unofficial and independent of the FDA.