510(k) K921977 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
SYNERGY SCREEN TEST, MODIFICATION
| Applicant | Baxter Healthcare Corp, West Sacramento CA, US |
| Decision | Substantially Equivalent, Oct 12, 1993 |
| Received | Apr 21, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921977
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.