The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Ims System.
Device ID | K993867 |
510k Number | K993867 |
Device Name: | BAYER ADVIA IMS SYSTEM |
Classification | Diazo Colorimetry, Bilirubin |
Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Contact | Gabriel J Muraca |
Correspondent | Gabriel J Muraca BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Product Code | CIG |
Subsequent Product Code | JGJ |
Subsequent Product Code | KLS |
Subsequent Product Code | KNK |
Subsequent Product Code | LCD |
Subsequent Product Code | LCP |
Subsequent Product Code | LDO |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-15 |
Decision Date | 2000-04-10 |
Summary: | summary |