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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K972094
Device Name TARGET CARDIAC TROPONIN I TEST
Applicant
Texas Immunology, Inc.
5400 Spur 248 Bldg. 2 Suite 6
Tyler,  TX  75707
Applicant Contact CHARLES W GILL
Correspondent
Texas Immunology, Inc.
5400 Spur 248 Bldg. 2 Suite 6
Tyler,  TX  75707
Correspondent Contact CHARLES W GILL
Regulation Number862.1215
Classification Product Code
MMI  
Date Received06/04/1997
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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