510(k) K981178 ยท GGN Plasma, Coagulation Control
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
| Applicant | Cardiovascular Diagnostics, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Apr 27, 1998 |
| Received | Apr 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981178
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.