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FDA 510(k) Application Details - K992191
Device Classification Name
Epstein-Barr Virus, Other
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510(K) Number
K992191
Device Name
Epstein-Barr Virus, Other
Applicant
DIASORIN, INC.
9175 GUIFORD RD.
COLUMBIA, MD 21046 US
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Contact
JUDITH J SMITH
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Regulation Number
866.3235
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Classification Product Code
LSE
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More FDA Info for this Product Code
Date Received
06/28/1999
Decision Date
07/12/1999
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
Y
Expedited Review
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