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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Factor 4 Radioimmunoassay
510(k) Number K040293
Device Name HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
Applicant
Akers Laboratories, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Applicant Contact BARBARA A BAGBY
Correspondent
Akers Laboratories, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Correspondent Contact BARBARA A BAGBY
Regulation Number864.7695
Classification Product Code
LCO  
Date Received02/06/2004
Decision Date 05/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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