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FDA 510(k) Application Details - K951549
Device Classification Name
Test, Antigen, Nuclear, Epstein-Barr Virus
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510(K) Number
K951549
Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Applicant
IMMUNO PROBE, INC.
COLUMBIA SQUARE
555 THIRTEENTH STREET NW
WASHINGTON, DC 20004-1109 US
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Contact
EDWARD C WILSON, JR.
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Regulation Number
866.3235
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Classification Product Code
LLM
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More FDA Info for this Product Code
Date Received
04/04/1995
Decision Date
04/29/1996
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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