Panels › Microbiology › Product code POC · Class 2
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Regulation 866.1640
1510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in POC
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 3 | 0 |
| Check-Points Health B.V. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2026 | K261867 | Xpert Carba-R Cepheid® | POC |
| Aug 29, 2019 | K190613 | BD MAX Check-Points CPO Check-Points Health B.V., NL | POC |
| Jan 9, 2018 | K173263 | Xpert Carba-R Cepheid | POC |
| Jun 29, 2016 | K160901 | Xpert Carba-R Cepheid | POC |
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