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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K922680
Device Name DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
DU PONT-BMP22/1152
WILMINGTON,  DE  19880
Applicant Contact CHRISTOPHER BENTSEN
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
DU PONT-BMP22/1152
WILMINGTON,  DE  19880
Correspondent Contact CHRISTOPHER BENTSEN
Regulation Number862.2160
Classification Product Code
JJE  
Date Received06/04/1992
Decision Date 08/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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