510(k) K974108 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 26, 1997 |
| Received | Oct 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974108
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.