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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K922700
Device Name DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
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 Number862.1215
Classification Product Code
JHY  
Date Received06/04/1992
Decision Date 08/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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