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FDA 510(k) Application Details - K990842
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
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510(K) Number
K990842
Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant
SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO, TX 78240 US
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Contact
J. WESSLING
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Regulation Number
866.3405
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Classification Product Code
LIQ
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Date Received
03/15/1999
Decision Date
08/09/1999
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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