510(k) K964053 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
HEMOCUE GLUCOTROL
| Applicant | Direct Solutions, Westford MA, US |
| Decision | Substantially Equivalent, Nov 1, 1996 |
| Received | Sep 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964053
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.