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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 K901542
Device Name E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE
Applicant
Source Scientific Systems, Inc.
7390 Lincoln Way
Garden Grove,  CA  92641
Applicant Contact MICHAEL GENDREAU
Correspondent
Source Scientific Systems, Inc.
7390 Lincoln Way
Garden Grove,  CA  92641
Correspondent Contact MICHAEL GENDREAU
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received04/02/1990
Decision Date 04/26/1990
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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