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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K811194
Device Name HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
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 Number862.2160
Classification Product Code
JJE  
Date Received04/30/1981
Decision Date 05/27/1981
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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