FDA 510(k) Application Details - K964872

Device Classification Name Antigen, Cf, (Including Cf Control), Varicella-Zoster

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510(K) Number K964872
Device Name Antigen, Cf, (Including Cf Control), Varicella-Zoster
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 866.3900

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Classification Product Code GQW
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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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