510(k) K915281 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
SEROLISA CHLAMYDIA IGG TEST KIT
| Applicant | Savyon Diagnostics , Ltd., Sheva, Israel, IL |
| Decision | Substantially Equivalent, Mar 23, 1992 |
| Received | Nov 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915281
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.