510(k) K970527 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ABBOTT HCG SERUM CONTROLS
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Mar 3, 1997 |
| Received | Feb 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970527
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.