510(k) K022409 ยท JHT Chromatographic Separation, Cpk Isoenzymes
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Sep 30, 2002 |
| Received | Jul 24, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022409
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.