High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
Regulation 866.6085
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SBY
| Company | 510(k)s | Recalls |
|---|---|---|
| Life Technologies Corporation | 1 | 0 |
| Personal Genome Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2026 | K260827 | Oncomine Dx Express Test Life Technologies Corporation | SBY |
| Aug 1, 2024 | DEN230046 | PGDx elio plasma focus Dx Personal Genome Diagnostics, Inc. | SBY |
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