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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 K832783
Device Name MICRO-SAMPLE OSMOMETER 3M0
Applicant
Advanced Instruments, Inc.
Shorashim
Correspondent
Advanced Instruments, Inc.
Shorashim
Regulation Number862.2730
Classification Product Code
JJM  
Date Received08/16/1983
Decision Date 11/28/1983
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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