FDA 510(k) Application Details - K961961

Device Classification Name Antisera, All Groups, Salmonella Spp.

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510(K) Number K961961
Device Name Antisera, All Groups, Salmonella Spp.
Applicant SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO, TX 78240 US
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Contact HARBI SHADFAN
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Regulation Number 866.3550

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Classification Product Code GRM
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Date Received 05/20/1996
Decision Date 06/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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