FDA 510(k) Application Details - K020387

Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological

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510(K) Number K020387
Device Name System, Test, Radioallergosorbent (Rast) Immunological
Applicant IMMUNETECH CORPORATION
P.O. BOX 9433
17394 VIA DEL BRAVO
RANCHO SANTA FE, CA 92067 US
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Contact VIVIANNE NOETZEL
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Regulation Number 866.5750

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Classification Product Code DHB
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Date Received 02/05/2002
Decision Date 04/17/2002
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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