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FDA 510(k) K132167, I-CHROMA IFOB WITH I-CHROMA READER, by Boditech Med, Inc.

FDA 510(k) K132167, I-CHROMA IFOB WITH I-CHROMA READER, by Boditech Med, Inc.

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510(K) Number: K132167
Device Name: I-CHROMA IFOB WITH I-CHROMA READER
Manufacturer: Boditech Med, Inc.
Device Classification Name: automated occult blood analyzer
Regulation Number: 864.6550
Classification Product Code: OOX
Date Received: 07/12/2013
Decision Date: 05/02/2014
Regulation Medical Specialty: Hematology
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