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FDA 510(k), K113546, ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
FDA 510(k), K113546, ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
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510(K) Number: K113546
Device Name: ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
Manufacturer: Roche Diagnostics
Device Classification Name: system, test, vitamin d
Regulation Number: 862.1825
Classification Product Code: MRG
Date Received: 12/01/2011
Decision Date: 07/24/2012
Regulation Medical Specialty: Clinical Chemistry
Device Name: ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
Manufacturer: Roche Diagnostics
Device Classification Name: system, test, vitamin d
Regulation Number: 862.1825
Classification Product Code: MRG
Date Received: 12/01/2011
Decision Date: 07/24/2012
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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