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FDA 510(k) Application Details - K021429
Device Classification Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
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510(K) Number
K021429
Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant
FOCUS TECHNOLOGIES, INC.
10703 PROGRESS WAY
CYPRESS, CA 90630-4737 US
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Contact
MICHAEL J WAGNER
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Regulation Number
866.3305
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Classification Product Code
MXJ
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More FDA Info for this Product Code
Date Received
05/03/2002
Decision Date
07/29/2002
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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