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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K941050
Device Name DUPONT ACA STAR
Applicant
Dupont Medical Products
Rte. 896
Newark,  DE  19702
Applicant Contact REBECCA S AYASH
Correspondent
Dupont Medical Products
Rte. 896
Newark,  DE  19702
Correspondent Contact REBECCA S AYASH
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/07/1994
Decision Date 11/10/1994
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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