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FDA 510(k) Application Details - K973941
Device Classification Name
Test, Antigen, Nuclear, Epstein-Barr Virus
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510(K) Number
K973941
Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Applicant
GenBio
15222 AVE. OF SCIENCE, SUITE A
SAN DIEGO, CA 92128 US
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Contact
Bryan Kiehl
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Regulation Number
866.3235
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Classification Product Code
LLM
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Date Received
10/15/1997
Decision Date
08/10/1998
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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