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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K871550
Device Name PFI-20 POLARIZING FLUORIMETER
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 Number862.2560
Classification Product Code
KHO  
Date Received04/22/1987
Decision Date 07/01/1987
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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