FDA 510(k) Application Details - K081527

Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2

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510(K) Number K081527
Device Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
Applicant MILLIPORE CORPORATION
28820 SINGLE OAK DR.
TEMECULA, CA 92590 US
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Contact ALISHA VU
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Regulation Number 866.3305

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Classification Product Code GQL
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Date Received 06/02/2008
Decision Date 04/01/2009
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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