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FDA 510(k) Application Details - K041439
Device Classification Name
More FDA Info for this Device
510(K) Number
K041439
Device Name
SAS INFLUENZA B TEST
Applicant
SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO, TX 78240 US
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Contact
RICARDO R MARTINEZ
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PSZ
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More FDA Info for this Product Code
Date Received
06/01/2004
Decision Date
07/22/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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