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510(k) K051072

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM by Bio-Rad Laboratories, Inc. — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2005
Date Received
April 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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