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FDA 510(k) Application Details - K083729
Device Classification Name
Test, Time, Partial Thromboplastin
More FDA Info for this Device
510(K) Number
K083729
Device Name
Test, Time, Partial Thromboplastin
Applicant
ANIARA DIAGNOSTICA ,LLC
6560 GOVE COURT
MASON, OH 45040 US
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Contact
OLA ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
864.7925
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Classification Product Code
GGW
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More FDA Info for this Product Code
Date Received
12/16/2008
Decision Date
05/08/2009
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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