The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Additional Ims Assays For The Bayer Advia Ims System.
Device ID | K992399 |
510k Number | K992399 |
Device Name: | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM |
Classification | Bromcresol Green Dye-binding, Albumin |
Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Contact | Gabriel J Muracaa Jr |
Correspondent | Gabriel J Muracaa Jr BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Product Code | CIX |
Subsequent Product Code | CEM |
Subsequent Product Code | CEO |
Subsequent Product Code | CGZ |
Subsequent Product Code | CHH |
Subsequent Product Code | CHS |
Subsequent Product Code | CIG |
Subsequent Product Code | JGS |
Subsequent Product Code | KXT |
CFR Regulation Number | 862.1035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-19 |
Decision Date | 1999-09-15 |
Summary: | summary |