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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digoxin Control Serum, Ria
510(k) Number K953393
Device Name TOX PERFECT A TUBE
Applicant
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Applicant Contact CHARLES A HAY
Correspondent
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Correspondent Contact CHARLES A HAY
Regulation Number862.3280
Classification Product Code
DMP  
Date Received07/14/1995
Decision Date 10/06/1995
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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