FDA Product Code OYJ: Dna Specimen Collection, Saliva
A Collection Device Intended For Use In The Non-invasive Collection Of Saliva Samples For Clinical Dna Testing.
Leading manufacturers include DNA Genotek, Inc. and Ancestry Genomics, Inc..
7
Total
7
Cleared
267d
Avg days
2011
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Dna Specimen Collection, Saliva Devices (Product Code OYJ)
7 devices
Cleared
Oct 27, 2022
ORAcollect®•Dx
DNA Genotek, Inc.
Chemistry
423d
Cleared
Aug 13, 2020
AncestryDNA Saliva Collection Kit
Ancestry Genomics, Inc.
Chemistry
300d
Cleared
Jan 14, 2020
Oragene®•Dx
DNA Genotek, Inc.
Chemistry
90d
Cleared
May 26, 2016
ORAcollect.Dx
DNA Genotek, Inc.
Chemistry
269d
Cleared
May 26, 2016
Oragene Dx
DNA Genotek, Inc.
Chemistry
261d
Cleared
Feb 19, 2015
ORAGENE DX OGD-500.001
DNA Genotek, Inc.
Chemistry
266d
Cleared
Dec 02, 2011
ORAGENE-DX OGD-500
DNA Genotek, Inc.
Chemistry
263d
About Product Code OYJ - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code OYJ since 2011, with 7 receiving FDA clearance (average review time: 267 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.