510(k) K110412 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IDS-ISYS IFG-I CONTROL SET
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, Tyne & Wear, GB |
| Decision | Substantially Equivalent, Mar 16, 2011 |
| Received | Feb 14, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K110412
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.