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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diacetyl-Monoxime, Urea Nitrogen
510(k) Number K861775
Device Name TWIN BUN/GLUCOSE
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact SUE SMITH
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact SUE SMITH
Regulation Number862.1770
Classification Product Code
CDW  
Date Received05/08/1986
Decision Date 06/27/1986
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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