510(k) K082205 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
FACTOR VIII ANTIBODY SCREEN
| Applicant | Genetic Testing Institute, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 20, 2008 |
| Received | Aug 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082205
No recall in the FDA data names this 510(k).
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