The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Ammonia Assay For The Advia Integrated Modular System.
| Device ID | K021151 |
| 510k Number | K021151 |
| Device Name: | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
| Classification | Enzymatic Method, Ammonia |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds 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 | 2002-04-10 |
| Decision Date | 2002-07-13 |
| Summary: | summary |