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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Purple Dye-Binding, Albumin
510(k) Number K844426
Device Name ALBUMIN BCP
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 Number862.1035
Classification Product Code
CJW  
Date Received11/15/1984
Decision Date 01/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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