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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K771496
Device Name CHEMCODE/CHEMTEK SYSTEM
Applicant
BOEHRINGER MANNHEIM CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BOEHRINGER MANNHEIM CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/05/1977
Decision Date 10/25/1977
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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