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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K881366
Device Name BIOTROL BUN ENZYMATIQUE UV H.P.
Applicant
BIOTROL, USA, INC.
5 GREAT VALLEY PKWY, SUITE 248
GREAT VALLEY CORP. CENTER
MALVERN,  PA  19355
Applicant Contact ALLAN C MURPHY
Correspondent
BIOTROL, USA, INC.
5 GREAT VALLEY PKWY, SUITE 248
GREAT VALLEY CORP. CENTER
MALVERN,  PA  19355
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received03/31/1988
Decision Date 05/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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