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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Procainamide
510(k) Number K831400
Device Name AMES TDA PROCAINAMIDE TEST
Applicant
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3320
Classification Product Code
LAR  
Date Received04/29/1983
Decision Date 06/02/1983
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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