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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric, Total Protein
510(k) Number K913615
Device Name URINARY/CSF PROTEIN
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact JOHN D STEVENS
Regulation Number862.1635
Classification Product Code
JGQ  
Date Received08/13/1991
Decision Date 09/13/1991
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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