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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 K895745
Device Name SICKLE CELL SOLUBILITY TEST KIT
Applicant
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Applicant Contact CARL R BURKS
Correspondent
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Correspondent Contact CARL R BURKS
Regulation Number864.7825
Classification Product Code
JBB  
Date Received09/26/1989
Decision Date 11/29/1989
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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