510(k) K991299 ยท JHT Chromatographic Separation, Cpk Isoenzymes
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, May 28, 1999 |
| Received | Apr 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991299
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.