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FDA 510(k) Application Details - K060968
Device Classification Name
Plasma, Control, Normal
More FDA Info for this Device
510(K) Number
K060968
Device Name
Plasma, Control, Normal
Applicant
WORTHAM LABORATORIES INC
6340 BONNY OAKS DR.
CHATTANOOGA, TN 37416 US
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Contact
LEON WORTHAM
Other 510(k) Applications for this Contact
Regulation Number
864.5425
More FDA Info for this Regulation Number
Classification Product Code
GIZ
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More FDA Info for this Product Code
Date Received
04/07/2006
Decision Date
05/15/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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