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FDA 510(k) Application Details - K964875
Device Classification Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
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510(K) Number
K964875
Device Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Applicant
VIRAL ANTIGENS, INC.
5171 WILFONG RD.
MEMPHIS, TN 38134 US
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Contact
TERRY S RATCLIFFE
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Regulation Number
866.3175
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Classification Product Code
GQH
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Date Received
12/05/1996
Decision Date
03/18/1997
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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