The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Advia Chemistry Total Bilirubin_2.
| Device ID | K063845 |
| 510k Number | K063845 |
| Device Name: | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 |
| Classification | Enzymatic Method, Bilirubin |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Philip Liu |
| Correspondent | Philip Liu BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JFM |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-27 |
| Decision Date | 2007-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595818 | K063845 | 000 |
| 00630414513072 | K063845 | 000 |
| 00630414513058 | K063845 | 000 |