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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Ferritin, Antigen, Antiserum, Control
510(k) Number K883493
Device Name TECHNICON DPA-1 IMMUNOGLOBULIN M
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact LEONARD A DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact LEONARD A DWARICA
Regulation Number866.5550
Classification Product Code
DFL  
Date Received08/16/1988
Decision Date 09/22/1988
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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