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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, Theophylline
510(k) Number K812518
Device Name AMES TDA THEOPHYLLINE TEST
Applicant
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3880
Classification Product Code
LER  
Date Received09/02/1981
Decision Date 09/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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