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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 K934257
Device Name U-TROL LIQUID URINE DIPSTICK CONTROL
Applicant
P.T. Meditrol
Bandung 40181
Indonesia,  ID
Applicant Contact AWANG BENNEDICT, PHD.
Correspondent
P.T. Meditrol
Bandung 40181
Indonesia,  ID
Correspondent Contact AWANG BENNEDICT, PHD.
Regulation Number862.1660
Classification Product Code
JJW  
Date Received08/31/1993
Decision Date 11/26/1993
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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