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FDA 510(k) Application Details - K020914
Device Classification Name
Activated Whole Blood Clotting Time
More FDA Info for this Device
510(K) Number
K020914
Device Name
Activated Whole Blood Clotting Time
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT, TX 77704 US
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Contact
PATRICIA FRANKS
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Regulation Number
864.7140
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Classification Product Code
JBP
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More FDA Info for this Product Code
Date Received
03/21/2002
Decision Date
05/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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