The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Diagnostics Acs:180 Vb12, Bayer Diagnostics Advia Centaue Vb12.
| Device ID | K993571 |
| 510k Number | K993571 |
| Device Name: | BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-21 |
| Decision Date | 1999-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600314 | K993571 | 000 |
| 00630414294100 | K993571 | 000 |
| 00630414294261 | K993571 | 000 |
| 00630414054124 | K993571 | 000 |
| 00630414124780 | K993571 | 000 |
| 00630414124919 | K993571 | 000 |
| 00630414124926 | K993571 | 000 |
| 00630414175300 | K993571 | 000 |
| 00630414177168 | K993571 | 000 |
| 00630414177175 | K993571 | 000 |
| 00630414204758 | K993571 | 000 |
| 00630414443010 | K993571 | 000 |
| 00630414598338 | K993571 | 000 |
| 00630414598345 | K993571 | 000 |
| 00630414600277 | K993571 | 000 |
| 00630414600284 | K993571 | 000 |
| 00630414600291 | K993571 | 000 |
| 00630414600307 | K993571 | 000 |