510(k) K922754 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
TANDEM-E IGE II CALIBRATION VERIFICATION SET
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 17, 1993 |
| Received | Jun 8, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922754
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.