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FDA 510(k) Application Details - K952721
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rubella
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510(K) Number
K952721
Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 987
COLUMBUS, NE 68602-0987 US
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Contact
ROBERT E JAMES
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Regulation Number
866.3510
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Classification Product Code
LFX
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More FDA Info for this Product Code
Date Received
06/15/1995
Decision Date
12/20/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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