510(k) DEN230046 ยท SBY High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
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| Applicant | Personal Genome Diagnostics, Inc., Blatimore MD, US |
| Decision | Unknown, Aug 1, 2024 |
| Received | Jun 30, 2023 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN230046
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.