FDA 510(k) Application Details - K093415

Device Classification Name Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

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510(K) Number K093415
Device Name Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
Applicant DIAGNOSTIC HYBRIDS, INC.
1055 EAST STATE STREET
SUITE 100
ATHENS, OH 45701 US
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Contact Ronald H Lollar
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Regulation Number 866.3400

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Classification Product Code GQS
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Date Received 11/02/2009
Decision Date 12/23/2009
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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