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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin S
510(k) Number K874429
Device Name HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12
Applicant
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Applicant Contact BARBARA H SNEADE
Correspondent
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Correspondent Contact BARBARA H SNEADE
Regulation Number864.7415
Classification Product Code
GIQ  
Date Received10/28/1987
Decision Date 02/04/1988
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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