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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 K862178
Device Name ISOPURE LC SYSTEM
Applicant
The Perkin-Elmer Corp.
761 Main Ave.
Norwalk,  CT  06859
Applicant Contact D. M VANDERGRIFT
Correspondent
The Perkin-Elmer Corp.
761 Main Ave.
Norwalk,  CT  06859
Correspondent Contact D. M VANDERGRIFT
Regulation Number862.2260
Classification Product Code
LDM  
Date Received06/09/1986
Decision Date 07/14/1986
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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