510(k) K981206 ยท GKP Instrument, Coagulation, Automated
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
| Applicant | Cardiovascular Diagnostics, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, May 26, 1998 |
| Received | Apr 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981206
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.