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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, primary
510(k) Number K810963
Device Name BIO SET TM SUBSTRATE CALIBRATORS
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 Number862.1150
Classification Product Code
JIS  
Date Received04/08/1981
Decision Date 04/17/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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