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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
510(k) Number K821669
Device Name AMES TDA GENTAMICIN TEST
Applicant
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3450
Classification Product Code
DJB  
Date Received06/07/1982
Decision Date 12/15/1982
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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