510(k) K875159 ยท GQI Antiserum, Cf, Cytomegalovirus
DETECTADOT SYSTEM 2000 CMV IGG TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 6, 1988 |
| Received | Dec 16, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875159
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.