Bayer Corp. · Class II · Cleared Dec 17, 2002
| K-number | K022288 |
| Device name | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM |
| Applicant | Bayer Corp. |
| Product code | LTJ |
| Device class | Class II |
| Decision date | Dec 17, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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