510(k) K853553 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
DIASCAN CONTROL
| Applicant | Home Diagnostics, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Sep 16, 1985 |
| Received | Aug 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853553
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.