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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K861756
Device Name V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
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 Number862.1660
Classification Product Code
JJW  
Date Received05/06/1986
Decision Date 07/07/1986
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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