510(k) K230852 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
HemosIL Chromogenic Factor IX
| Applicant | Instrumentation Laboratory Company, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 13, 2023 |
| Received | Mar 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230852
No recall in the FDA data names this 510(k).
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