The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Rapidpoint 405 System.
| Device ID | K020616 |
| 510k Number | K020616 |
| Device Name: | BAYER RAPIDPOINT 405 SYSTEM |
| Classification | System, Hemoglobin, Automated |
| Applicant | BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-25 |
| Decision Date | 2002-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414947549 | K020616 | 000 |
| 00630414947532 | K020616 | 000 |
| 00630414947525 | K020616 | 000 |
| 00630414553610 | K020616 | 000 |
| 00630414553603 | K020616 | 000 |
| 00630414477855 | K020616 | 000 |
| 00630414477848 | K020616 | 000 |
| 00630414477831 | K020616 | 000 |
| 00630414477824 | K020616 | 000 |