510(k) K100716 ยท GGN Plasma, Coagulation Control
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
| Applicant | Aalto Scientific, Ltd., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 23, 2011 |
| Received | Mar 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100716
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.