FDA 510(k) Application Details - K034057

Device Classification Name Ige, Antigen, Antiserum, Control

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510(K) Number K034057
Device Name Ige, Antigen, Antiserum, Control
Applicant ADIATEC SA
5 PASSAGE DOUARD
4 RUE DES OLIVETTES
NANTES 44000 FR
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Contact JOEL LESSER
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Regulation Number 866.5510

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Classification Product Code DGC
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Date Received 12/30/2003
Decision Date 03/09/2004
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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