FDA 510(k), K091283, CAPILLARYS NEONAT HB (PN 2006)

FDA 510(k), K091283, CAPILLARYS NEONAT HB (PN 2006)

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510(K) Number: K091283
Device Name: CAPILLARYS NEONAT HB (PN 2006)
Manufacturer:
Device Classification Name: Abnormal Hemoglobin Quantitation
Regulation Number: 864.7415
Classification Product Code: GKA
Date Received: 05/01/2009
Decision Date: 02/22/2010
Regulation Medical Specialty: Hematology
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