510(k) K034048 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
R&D GLU-LINE HEMATOLOGY CONTROL
| Applicant | R&D Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 10, 2004 |
| Received | Dec 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034048
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.