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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 K885307
Device Name FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
Applicant
Alerchek, Inc.
203 Anderson St.
Portland,  ME  04101
Applicant Contact WAYNE M HENRY
Correspondent
Alerchek, Inc.
203 Anderson St.
Portland,  ME  04101
Correspondent Contact WAYNE M HENRY
Regulation Number866.5510
Classification Product Code
DGC  
Date Received12/27/1988
Decision Date 03/08/1989
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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