FDA 510(k) Application Details - K950169

Device Classification Name Anti-Ribosomal P Antibodies

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510(K) Number K950169
Device Name Anti-Ribosomal P Antibodies
Applicant HOGAN & HARTSON
COLUMBIA SQUARE
555 THIRTEENTH STREET N.W.
WASHINGTON, DC 20004 US
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Contact EDWARD C WILSON, JR.
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Regulation Number 866.5100

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Classification Product Code MQA
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Date Received 01/17/1995
Decision Date 05/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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