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FDA 510(k), K110619, ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
FDA 510(k), K110619, ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
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510(K) Number: K110619
Device Name: ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
Manufacturer: BIOKIT S.A.
Device Classification Name: system, test, vitamin d
Regulation Number: 862.1825
Classification Product Code: MRG
Date Received: 03/03/2011
Decision Date: 11/23/2011
Regulation Medical Specialty: Clinical Chemistry
Device Name: ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
Manufacturer: BIOKIT S.A.
Device Classification Name: system, test, vitamin d
Regulation Number: 862.1825
Classification Product Code: MRG
Date Received: 03/03/2011
Decision Date: 11/23/2011
Regulation Medical Specialty: Clinical Chemistry
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- Delivery: Approximately 1 to 2 weeks
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