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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Osmometer For Clinical Use
510(k) Number K842750
Device Name OSMOTIC PRESSURE AUTO & STAT OM-6010
Applicant
Kyoto Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kyoto Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2730
Classification Product Code
JJM  
Date Received07/13/1984
Decision Date 08/17/1984
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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