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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 K871679
Device Name FOCUS-GHB
Applicant
AWARENESS TECHNOLOGY, INC.
3481 SW PALM CITY SCH. RD.
P.O. BOX 1679
PALM CITY,  FL  34990
Applicant Contact MARY FREEMAN
Correspondent
AWARENESS TECHNOLOGY, INC.
3481 SW PALM CITY SCH. RD.
P.O. BOX 1679
PALM CITY,  FL  34990
Correspondent Contact MARY FREEMAN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received04/29/1987
Decision Date 07/28/1987
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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