Genbio · Class I · Cleared May 5, 1997
| K-number | K963054 |
| Device name | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) |
| Applicant | Genbio |
| Product code | LJZ |
| Device class | Class I |
| Decision date | May 5, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.3375 |
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