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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 K911092
Device Name OSMOMETER MODEL 2400
Applicant
Advanced Instruments, Inc.
1000 Highland Ave.
Needham Heights,  MA  02194
Applicant Contact DOUGLAS GUERETTE
Correspondent
Advanced Instruments, Inc.
1000 Highland Ave.
Needham Heights,  MA  02194
Correspondent Contact DOUGLAS GUERETTE
Regulation Number862.2730
Classification Product Code
JJM  
Date Received03/11/1991
Decision Date 05/22/1991
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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