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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solubility, Hemoglobin, Abnormal
510(k) Number K932872
Device Name SICKLE CELL TEST KIT
Applicant
HISTO-MED, INC.
1104 SHADICK DR.
ORANGE CITY,  FL  32763
Applicant Contact WALTER LAMBERT
Correspondent
HISTO-MED, INC.
1104 SHADICK DR.
ORANGE CITY,  FL  32763
Correspondent Contact WALTER LAMBERT
Regulation Number864.7825
Classification Product Code
JBB  
Date Received06/14/1993
Decision Date 08/16/1993
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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