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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 K860027
Device Name FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY
Applicant
Alerchek, Inc.
203 Anderson St.
Portland,  ME  04101
Applicant Contact WAYNE HENRY
Correspondent
Alerchek, Inc.
203 Anderson St.
Portland,  ME  04101
Correspondent Contact WAYNE HENRY
Regulation Number866.5750
Classification Product Code
DHB  
Date Received01/03/1986
Decision Date 04/22/1986
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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