Bayer Corp. · Class II · Cleared Oct 22, 1997
| K-number | K971989 |
| Device name | TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
| Applicant | Bayer Corp. |
| Product code | LGD |
| Device class | Class II |
| Decision date | Oct 22, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.3780 |
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