FDA 510(k), K132167, I-CHROMA IFOB WITH I-CHROMA READER

FDA 510(k), K132167, I-CHROMA IFOB WITH I-CHROMA READER

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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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