The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Additional Assays For Bayer Advia Ims System.
| Device ID | K000903 |
| 510k Number | K000903 |
| Device Name: | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Fredrick Clerie |
| Correspondent | Fredrick Clerie BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-21 |
| Decision Date | 2000-05-18 |