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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K954188
Device Name OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL
Applicant
Immunotech Corp.
160 B Larrabee Rd.
Westbrook,  ME  04092
Applicant Contact JAMEES W CHAMPLIN
Correspondent
Immunotech Corp.
160 B Larrabee Rd.
Westbrook,  ME  04092
Correspondent Contact JAMEES W CHAMPLIN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received09/06/1995
Decision Date 11/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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