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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Diphenylhydantoin
510(k) Number K831154
Device Name STRATUS PHENYTOIN FLUOROMETRIC ENZYME
Applicant
American Dade
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Dade
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3350
Classification Product Code
LES  
Date Received04/08/1983
Decision Date 05/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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