The following data is part of a premarket notification filed by Check-points Health B.v. with the FDA for Bd Max Check-points Cpo.
| Device ID | K190613 |
| 510k Number | K190613 |
| Device Name: | BD MAX Check-Points CPO |
| Classification | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen |
| Applicant | Check-Points Health B.V. Binnenhaven 5 Wageningen, NL 6709 |
| Contact | Pieter Vos |
| Correspondent | Pieter Vos Check-Points Health B.V. Binnenhaven 5 Wageningen, NL 6709 |
| Product Code | POC |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00180002781029 | K190613 | 000 |
| 00382904452629 | K190613 | 000 |