FDA Product Code
FDA Product Code POC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.1640
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261867 | Xpert Carba-R | Cepheid® | 2026-07-02 | Special | PDF ↗ |
| K190613 | BD MAX Check-Points CPO | Check-Points Health B.V. | 2019-08-29 | Traditional | PDF ↗ |
| K173263 | Xpert Carba-R | Cepheid | 2018-01-09 | Traditional | PDF ↗ |
| K160901 | Xpert Carba-R | Cepheid | 2016-06-29 | Traditional | PDF ↗ |
Product code POC · Class II · Microbiology. Data: openFDA.