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 |