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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatography (Liquid, Gel), Clinical Use
510(k) Number K843568
Device Name LIQUID CHROMATOGRAPH 400
Applicant
The Perkin-Elmer Corp.
Main Ave.
Norwalk,  CT  06859
Applicant Contact RALPH D CONLON
Correspondent
The Perkin-Elmer Corp.
Main Ave.
Norwalk,  CT  06859
Correspondent Contact RALPH D CONLON
Regulation Number862.2260
Classification Product Code
KZR  
Date Received09/10/1984
Decision Date 11/20/1984
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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