MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI— 510(k) K991299
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K991299 for MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI, Substantially Equivalent on 1999-05-28. Applicant: Princeton BioMeditech Corp..
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code JHT
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monmouth Junction, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.