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FDA 510(k) Application Details - K964424
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
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510(K) Number
K964424
Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant
TRINITY BIOTECH, INC.
3722 AVE. SAUSALILO
IRVINE, CA 92606-1849 US
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Contact
GRACE HOLLAND
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Regulation Number
866.3405
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Classification Product Code
LIQ
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Date Received
11/05/1996
Decision Date
08/08/1997
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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