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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K963680
Device Name TARGET MYOGLOBIN TEST
Applicant
Texas Immunology, Inc.
5400 Spur 248 Bldg. 2 Suite 6
Tyler,  TX  75707
Applicant Contact CHRALES W GILL
Correspondent
Texas Immunology, Inc.
5400 Spur 248 Bldg. 2 Suite 6
Tyler,  TX  75707
Correspondent Contact CHRALES W GILL
Regulation Number866.5680
Classification Product Code
DDR  
Date Received09/16/1996
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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