FDA 510(k) Application Details - K854875

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

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510(K) Number K854875
Device Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Applicant PHOTEC DIAGNOSTICS, INC.
101 EAST MAIN ST.
LITTLE FALLS, NJ US
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Contact ANN BAILEY
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Regulation Number 866.5580

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Classification Product Code DER
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Date Received 12/04/1985
Decision Date 01/24/1986
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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