FDA 510(k) Application Details - K951851

Device Classification Name Antigen, Iha, Cytomegalovirus

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510(K) Number K951851
Device Name Antigen, Iha, Cytomegalovirus
Applicant E.I. DUPONT DE NEMOURS & CO., INC.
BUILDING 500, MAILBOX 514
P.O. BOX 6101
NEWARK, DE 19714-6101 US
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Contact JAMES E KELLER
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Regulation Number 866.3175

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Classification Product Code LJO
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Date Received 04/21/1995
Decision Date 07/24/1996
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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