510(k) K912439 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 28, 1991 |
| Received | Jun 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912439
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.