FDA 510(k) Application Details - K020752

Device Classification Name System, Test, Anticardiolipin Immunological

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510(K) Number K020752
Device Name System, Test, Anticardiolipin Immunological
Applicant PHARMACIA DEUTSCHLAND GMBH
MUNZINGERSTRASSE 7
FREIBURG DE
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Contact MICHAEL LINSS
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Regulation Number 866.5660

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Classification Product Code MID
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Date Received 03/07/2002
Decision Date 05/02/2002
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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