The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Acetaminophen Assay For The Advia Integrated Modular System.
| Device ID | K020792 |
| 510k Number | K020792 |
| Device Name: | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
| Classification | Colorimetry, Acetaminophen |
| 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 | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-11 |
| Decision Date | 2002-07-11 |
| Summary: | summary |