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
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.