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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Vancomycin
510(k) Number K945125
Device Name DUPONT ACA VANCOMYCIN (VANC) METHOD
Applicant
The DU Pont Co.
P.O. Box 80022, Bmp22-1166
Wilimington,  DE  19880 -0022
Applicant Contact JOSE L TORO
Correspondent
The DU Pont Co.
P.O. Box 80022, Bmp22-1166
Wilimington,  DE  19880 -0022
Correspondent Contact JOSE L TORO
Regulation Number862.3950
Classification Product Code
LEH  
Date Received10/19/1994
Decision Date 03/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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