510(k) K951359 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
| Applicant | Bayer Corp., Middletown VA, US |
| Decision | Substantially Equivalent, Apr 15, 1996 |
| Received | Mar 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951359
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.