FDA 510(k) Application Details - K041439

Device Classification Name

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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
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Regulation Number

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Classification Product Code PSZ
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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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