510(k) K922588 ยท JSS Kit, Identification, Enterobacteriaceae
ROCHE ENTEROTUBE II
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Sep 11, 1992 |
| Received | Jun 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922588
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.