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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
510(k) Number K933934
Device Name GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact LEO BRESSLER
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact LEO BRESSLER
Regulation Number864.7360
Classification Product Code
JBF  
Subsequent Product Code
JBG  
Date Received08/11/1993
Decision Date 06/29/1995
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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