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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 K884864
Device Name PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
Applicant
The Perkin-Elmer Corp.
761 Main Ave.
Norwalk,  CT  06859
Applicant Contact RAYMOND M TRENCK
Correspondent
The Perkin-Elmer Corp.
761 Main Ave.
Norwalk,  CT  06859
Correspondent Contact RAYMOND M TRENCK
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received11/22/1988
Decision Date 02/10/1989
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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