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 |