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 (invitro Diagnostic System With 5 Additional Assays).
Device ID | K993711 |
510k Number | K993711 |
Device Name: | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) |
Classification | System, Test, Beta-2-microglobulin Immunological |
Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Contact | Gabriel Muraca |
Correspondent | Gabriel Muraca BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Product Code | JZG |
Subsequent Product Code | DDR |
Subsequent Product Code | DHA |
Subsequent Product Code | JHW |
Subsequent Product Code | JLW |
Subsequent Product Code | JMG |
CFR Regulation Number | 866.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-03 |
Decision Date | 1999-12-16 |
Summary: | summary |