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FDA 510(k) Application Details - K132352
Device Classification Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
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510(K) Number
K132352
Device Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Applicant
SA SCIENTIFIC LTD.
4919 GOLDEN QUAIL
SAN ANTONIO, TX 78240 US
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Contact
Nelson Torres
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Regulation Number
866.3330
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Classification Product Code
GNX
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More FDA Info for this Product Code
Date Received
07/29/2013
Decision Date
08/22/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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