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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K771802
Device Name ACA IRON CALIBRATOR
Applicant
E.I. Dupont DE Nemours & Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIT  
Date Received09/23/1977
Decision Date 10/25/1977
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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