510(k) K934383 ยท GTZ Antisera, All Groups, Streptococcus Spp.
PROLEX (STREPTOCCAL GROUPING LATEX KIT)
| Applicant | Pro-Lab, Inc., Richmond Hill, Ontario, CA |
| Decision | Substantially Equivalent, Jan 27, 1995 |
| Received | Sep 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934383
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.