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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K875125
Device Name PROGENE(TM) IGE TEST
Applicant
Progene Corp.
6811 W. 63rd St.
Overland Park,  KS  66202
Applicant Contact GEORGE CHRISTOFFERSE
Correspondent
Progene Corp.
6811 W. 63rd St.
Overland Park,  KS  66202
Correspondent Contact GEORGE CHRISTOFFERSE
Regulation Number866.5750
Classification Product Code
DHB  
Date Received12/15/1987
Decision Date 02/25/1988
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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