510(k) K882534 ยท LIR Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jul 12, 1988 |
| Received | Jun 21, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882534
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.