510(k) K952819 ยท GTZ Antisera, All Groups, Streptococcus Spp.
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jan 26, 1996 |
| Received | Jun 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952819
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.