510(k) K033471 ยท GGW Test, Time, Partial Thromboplastin
PHOSPHOLIN ES AND CALCIUM CHLORIDE
| Applicant | R2 Diagnostics, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Feb 4, 2004 |
| Received | Nov 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033471
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.