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FDA 510(k) Application Details - K960465
Device Classification Name
Antisera, All Groups, Salmonella Spp.
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510(K) Number
K960465
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
01/30/1996
Decision Date
03/06/1996
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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