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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, digoxin (125-i), rabbit antibody, charcoal sep.
510(k) Number K790540
Device Name RIA TEST KIT, CENTRIA DIGOXIN
Applicant
VENTREX LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VENTREX LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.3320
Classification Product Code
DPB  
Date Received03/20/1979
Decision Date 04/23/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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