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FDA 510(k) Application Details - K984346
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
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510(K) Number
K984346
Device Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Applicant
MERIDIAN DIAGNOSTICS, INC.
3471 RIVER HILLS DR.
CINCINNATI, OH 45244 US
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Contact
ALAN NICHOL
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Regulation Number
866.3305
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Classification Product Code
LGC
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More FDA Info for this Product Code
Date Received
12/04/1998
Decision Date
06/25/1999
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
N
Expedited Review
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