Panels › Clinical Chemistry › Product code OYJ · Class 2
Dna Specimen Collection, Saliva
Regulation 862.1675
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OYJ
| Company | 510(k)s | Recalls |
|---|---|---|
| DNA Genotek, Inc. | 6 | 1 |
| Ancestry Genomics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 2022 | K212745 | ORAcollect®Dx DNA Genotek, Inc., CA | OYJ |
| Aug 13, 2020 | K192947 | AncestryDNA Saliva Collection Kit Ancestry Genomics, Inc. | OYJ |
| Jan 14, 2020 | K192920 | Oragene®Dx DNA Genotek, Inc., CA | OYJ |
| May 26, 2016 | K152556 | Oragene Dx DNA Genotek, Inc., CA | OYJ |
| May 26, 2016 | K152464 | ORAcollect.Dx DNA Genotek, Inc., CA | OYJ |
| Feb 19, 2015 | K141410 | ORAGENE DX OGD-500.001 DNA Genotek, Inc., CA | OYJ |
| Dec 2, 2011 | K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 DNA Genotek, Inc., CA | OYJ |
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