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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 K864202
Device Name UTISCREEN(R) BACTERIAL ATP TEST
Applicant
Los Alamos Diagnostics
P.O. Box 1221
2470 E. Rd.
Los Alamos,  NM  87544
Applicant Contact ROSS U ROBINSON
Correspondent
Los Alamos Diagnostics
P.O. Box 1221
2470 E. Rd.
Los Alamos,  NM  87544
Correspondent Contact ROSS U ROBINSON
Regulation Number866.2660
Classification Product Code
JXA  
Date Received10/27/1986
Decision Date 02/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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