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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase
510(k) Number K823900
Device Name GLUCOSE-6-PHOSPHATE DEHYDROGENASE
Applicant
Alladin Diagnostic, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Alladin Diagnostic, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.7360
Classification Product Code
KQE  
Date Received12/30/1982
Decision Date 02/07/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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