510(k) K880665 ยท GTZ Antisera, All Groups, Streptococcus Spp.
MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
| Applicant | Allelix Diagnostics, Inc., Canada L4v 1p1, CA |
| Decision | Substantially Equivalent, Mar 1, 1988 |
| Received | Feb 18, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880665
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.