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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
510(k) Number K851649
Device Name APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
Applicant
PHOTEC DIAGNOSTICS, INC.
101 EAST MAIN ST.
LITTLE FALLS,  NJ  07424
Applicant Contact JAMES F MONGIARDO
Correspondent
PHOTEC DIAGNOSTICS, INC.
101 EAST MAIN ST.
LITTLE FALLS,  NJ  07424
Correspondent Contact JAMES F MONGIARDO
Regulation Number866.5580
Classification Product Code
DER  
Date Received04/22/1985
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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