FDA 510(k) Application Details - K872078

Device Classification Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control

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510(K) Number K872078
Device Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Applicant SOLOMON PARK RESEARCH LABORATORIES
12815 NE 124TH ST., SUITE "I"
KIRKLAND, WA US
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Contact JOAN CORBETT-CLAPSHA
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Regulation Number 866.5580

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Classification Product Code DER
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Date Received 05/29/1987
Decision Date 06/18/1987
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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