The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Ammonia Assay For The Advia 1650.
| Device ID | K023841 |
| 510k Number | K023841 |
| Device Name: | AMMONIA ASSAY FOR THE ADVIA 1650 |
| Classification | Enzymatic Method, Ammonia |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2002-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414555898 | K023841 | 000 |