510(k) K251440 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
CRYOcheck Chromogenic Factor VIII
| Applicant | Precision Biologic, Inc., Dartmouth, CA |
| Decision | Substantially Equivalent, Aug 25, 2025 |
| Received | May 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251440
No recall in the FDA data names this 510(k).
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