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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation, High Pressure Liquid Chromatography
510(k) Number K780933
Device Name PREP I AUTOMATED SAMPLE PROCESSOR
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 Number862.2260
Classification Product Code
LDM  
Date Received06/07/1978
Decision Date 07/27/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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