510(k) K881243 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
| Applicant | Labsystems, Inc., Morton Grove IL, US |
| Decision | Substantially Equivalent, Apr 4, 1988 |
| Received | Mar 21, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881243
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.