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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K895294
Device Name PROGENE IGE BEAD EIA
Applicant
Progene Corp.
6811 W. 63rd St.
Overland Park,  KS  66202
Applicant Contact MARK S COLWELL
Correspondent
Progene Corp.
6811 W. 63rd St.
Overland Park,  KS  66202
Correspondent Contact MARK S COLWELL
Regulation Number866.5510
Classification Product Code
DGC  
Date Received08/25/1989
Decision Date 09/21/1989
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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