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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 K870673
Device Name ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Applicant Contact GRACE H SINGLES
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Correspondent Contact GRACE H SINGLES
Regulation Number862.1150
Classification Product Code
JIT  
Date Received02/19/1987
Decision Date 03/19/1987
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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