510(k) K822219 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
HUMAN PLASMA CONTROL FOR CEA-ROCHE
| Applicant | Hoffmann-La Roche, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 28, 1982 |
| Received | Jul 26, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822219
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.