510(k) K921075 ยท LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
PHADEBACT MONOCLONAL GC TEST, MODIFICATION
| Applicant | Karo Bio Diagnostics AB, S-141 44 Huddinge, Sweden, SC |
| Decision | Substantially Equivalent, May 22, 1992 |
| Received | Feb 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921075
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.