The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Advia Ims.
| Device ID | K001344 |
| 510k Number | K001344 |
| Device Name: | ADVIA IMS |
| Classification | Colorimetry, Cholinesterase |
| 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 | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-27 |
| Decision Date | 2000-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ADVIA IMS 75647484 2460809 Dead/Cancelled |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1999-02-24 |