510(k) K860923 ยท GTZ Antisera, All Groups, Streptococcus Spp.
EZ DETECT, 5 MINUTE STREP-A COLOR TEST
| Applicant | Self Care Systems, Inc., Newport Beach CA, US |
| Decision | Substantially Equivalent, May 16, 1986 |
| Received | Mar 11, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860923
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.