FDA 510(k) Application Details - K100227

Device Classification Name

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510(K) Number K100227
Device Name SAS FLUALERT A&B, SAS INFLUENZA A TEST
Applicant SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO, TX 78240 US
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Contact ROBBI PERRY
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Regulation Number

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Classification Product Code PSZ
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Date Received 01/26/2010
Decision Date 02/23/2010
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

FDA Source Information for K100227


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