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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Urine
510(k) Number K952246
Device Name TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
Applicant
Tri-Tech, Inc.
4019 Executive Park Blvd.,SE
Southport,  NC  28461
Applicant Contact WENDIE H WALKER
Correspondent
Tri-Tech, Inc.
4019 Executive Park Blvd.,SE
Southport,  NC  28461
Correspondent Contact WENDIE H WALKER
Regulation Number866.2660
Classification Product Code
JXA  
Subsequent Product Code
GJE  
Date Received05/12/1995
Decision Date 06/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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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