510(k) K920556 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 17, 1992 |
| Received | Feb 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920556
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.