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FDA 510(k) Application Details - K103603
Device Classification Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
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510(K) Number
K103603
Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG, NJ 08876 US
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Contact
EWA NADOLCZAK
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Regulation Number
866.3305
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Classification Product Code
MYF
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Date Received
12/08/2010
Decision Date
05/20/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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