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FDA 510(k) Application Details - K061014
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
More FDA Info for this Device
510(K) Number
K061014
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT, TX 77704-0752 US
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Contact
PATRICIA FRANKS
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
JPA
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More FDA Info for this Product Code
Date Received
04/13/2006
Decision Date
05/10/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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