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FDA 510(k) Application Details - K980598
Device Classification Name
Test, Antigen, Nuclear, Epstein-Barr Virus
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510(K) Number
K980598
Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Applicant
CLARK LABORATORIES, INC.
1306F BAILES LN.
FREDERICK, MD 21701 US
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Contact
WILLIAM L BOTELER, 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
02/17/1998
Decision Date
05/01/1998
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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