ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN— 510(k) K083260
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K083260 for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN, Substantially Equivalent on 2009-10-16. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- 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
- Indianapolis, IN, US
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More clearances from Roche Diagnostics
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