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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K012525
Device Name THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
Applicant
Thermo Dma, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact THOMAS DOLLAR
Correspondent
Thermo Dma, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact THOMAS DOLLAR
Regulation Number864.7470
Classification Product Code
LCP  
Date Received08/06/2001
Decision Date 10/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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