CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN— 510(k) K952360
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K952360 for CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN, Substantially Equivalent on 1995-08-14. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monmouth Junction, NJ, US
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