Panels › Microbiology › Product code SIH · Class 2
Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
Regulation 866.2920
1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SIH
| Company | 510(k)s | Recalls |
|---|---|---|
| DNA Genotek, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2026 | K254121 | Colli-PeeDx Urine Collection Kit DNA Genotek, Inc., CA | SIH |
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