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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stain, Fetal Hemoglobin
510(k) Number K892241
Device Name FETAL HEMOGLOBIN
Applicant
Sure-Tech Diagnostic Associates, Inc.
11012 Lin Valle Dr., Suite D
St. Louis,  MO  63123
Applicant Contact QUINCY E CRIDER,PHD
Correspondent
Sure-Tech Diagnostic Associates, Inc.
11012 Lin Valle Dr., Suite D
St. Louis,  MO  63123
Correspondent Contact QUINCY E CRIDER,PHD
Regulation Number864.7455
Classification Product Code
GHQ  
Date Received03/22/1989
Decision Date 05/17/1989
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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