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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, Digoxin
510(k) Number K854972
Device Name V-TREND DIG ENZYME IMMUNOASSAY TEST KIT
Applicant
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Applicant Contact AILENE HERRANEN
Correspondent
V-Tech, Inc.
270 E. Bonita Ave.
Pomona,  CA  91767
Correspondent Contact AILENE HERRANEN
Regulation Number862.3320
Classification Product Code
KXT  
Date Received12/11/1985
Decision Date 01/22/1986
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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