FDA 510(k) Applications for Medical Device Product Code "JHT"
(Chromatographic Separation, Cpk Isoenzymes)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991299 | PRINCETON BIOMEDITECH CORP. | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | 05/28/1999 |
| K022409 | SPECTRAL DIAGNOSTICS, INC. | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | 09/30/2002 |
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