Bayer Healthcare, LLC · Class II · Cleared Jul 6, 2006
| K-number | K061139 |
| Device name | BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS |
| Applicant | Bayer Healthcare, LLC |
| Product code | JIT |
| Device class | Class II |
| Decision date | Jul 6, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 862.1150 |
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