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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 K864177
Device Name N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
Applicant
Cls Co.
6190 Canyon Ct.
Anaheim Hills,  CA  92807
Applicant Contact D. M CHUN
Correspondent
Cls Co.
6190 Canyon Ct.
Anaheim Hills,  CA  92807
Correspondent Contact D. M CHUN
Regulation Number866.2660
Classification Product Code
JXA  
Date Received10/24/1986
Decision Date 02/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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