The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Complexed Prostate Specific Antigen (cpsa) Assay For The Bayer Advia Integrated Module System.
| Device ID | K022288 |
| 510k Number | K022288 |
| Device Name: | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2002-12-17 |
| Summary: | summary |