FDA 510(k) Application Details - K983954

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

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510(K) Number K983954
Device Name System, Test, Radioallergosorbent (Rast) Immunological
Applicant DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact EDWARD M LEVINE
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Regulation Number 866.5750

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Classification Product Code DHB
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Date Received 11/05/1998
Decision Date 12/17/1998
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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