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FDA 510(k) Application Details - K070645
Device Classification Name
Immunoassay, Anti-Seizure Drug
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510(K) Number
K070645
Device Name
Immunoassay, Anti-Seizure Drug
Applicant
SERADYN INC.
7998 GEORGETOWN RD. SUITE 1000
INDIANAPOLIS, IN 46268 US
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Contact
JACK ROGERS
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Regulation Number
862.3350
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Classification Product Code
NWM
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More FDA Info for this Product Code
Date Received
03/08/2007
Decision Date
05/17/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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