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FDA 510(k) Application Details - K951799
Device Classification Name
Antiserum, Cf, Varicella-Zoster
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510(K) Number
K951799
Device Name
Antiserum, Cf, Varicella-Zoster
Applicant
LIGHT DIAGNOSTICS
28835 SINGLE OAK DR.
TEMECULA, CA 92590 US
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Contact
DALE DEMBROW
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Regulation Number
866.3900
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Classification Product Code
GQX
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More FDA Info for this Product Code
Date Received
04/19/1995
Decision Date
03/20/1996
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
FDA Source Information for K951799
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