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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer
510(k) Number K852240
Device Name SMS, SCREEN MACHINE SYSTEM
Applicant
Pandex Laboratories, Inc.
909 Orchard St.
Mundelein,  IL  60060
Applicant Contact MARK S ELLIS
Correspondent
Pandex Laboratories, Inc.
909 Orchard St.
Mundelein,  IL  60060
Correspondent Contact MARK S ELLIS
Regulation Number866.4520
Classification Product Code
JZT  
Date Received05/23/1985
Decision Date 06/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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