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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 K881439
Device Name MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
Applicant
Los Alamos Diagnostics
P.O. Box 1221
2470 E. Rd.
Los Alamos,  NM  87544
Applicant Contact BETTY STRIETELMEIER
Correspondent
Los Alamos Diagnostics
P.O. Box 1221
2470 E. Rd.
Los Alamos,  NM  87544
Correspondent Contact BETTY STRIETELMEIER
Regulation Number866.2660
Classification Product Code
JXA  
Date Received04/05/1988
Decision Date 04/28/1988
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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