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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hemoglobin
510(k) Number K852136
Device Name PRECINORM HB
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 Number864.8625
Classification Product Code
GGM  
Date Received05/16/1985
Decision Date 07/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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