The following data is part of a premarket notification filed by Bayer Corp. with the FDA for 8 Additional Assays For The Bayer Advia 1650 Chemistry System.
| Device ID | K992662 |
| 510k Number | K992662 |
| Device Name: | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM |
| Classification | Apolipoproteins |
| 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 | MSJ |
| Subsequent Product Code | CFN |
| Subsequent Product Code | DCN |
| Subsequent Product Code | JNM |
| Subsequent Product Code | KHS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-09 |
| Decision Date | 2000-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596297 | K992662 | 000 |
| 00630414517674 | K992662 | 000 |
| 00630414596235 | K992662 | 000 |
| 00630414596242 | K992662 | 000 |
| 00630414513119 | K992662 | 000 |
| 00630414513126 | K992662 | 000 |
| 00630414513133 | K992662 | 000 |
| 00630414517711 | K992662 | 000 |
| 00630414595610 | K992662 | 000 |
| 00630414595627 | K992662 | 000 |
| 00630414596266 | K992662 | 000 |
| 00630414517636 | K992662 | 000 |