510(k) K893230 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 18, 1989 |
| Received | Apr 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893230
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.