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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cresolphthalein Complexone, Calcium
510(k) Number K871811
Device Name SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact CHERRI EMMONS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact CHERRI EMMONS
Regulation Number862.1145
Classification Product Code
CIC  
Date Received05/08/1987
Decision Date 05/26/1987
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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