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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K912246
Device Name TARGET MICROALBUMINURIA TEST
Applicant
Texas Immunology, Inc.
5400 Spur 248
Tyler,  TX  75707
Applicant Contact CHARLES W GILL
Correspondent
Texas Immunology, Inc.
5400 Spur 248
Tyler,  TX  75707
Correspondent Contact CHARLES W GILL
Regulation Number862.1645
Classification Product Code
JIR  
Date Received05/21/1991
Decision Date 07/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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