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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 K962056
Device Name ADVANCED MICRO-OSMOMETER MODEL 3300
Applicant
Advanced Instruments, Inc.
Two Technology Way
Norwood,  MA  02062
Applicant Contact DOUGLAS GUERETTE
Correspondent
Advanced Instruments, Inc.
Two Technology Way
Norwood,  MA  02062
Correspondent Contact DOUGLAS GUERETTE
Regulation Number862.2730
Classification Product Code
JJM  
Date Received05/28/1996
Decision Date 07/11/1996
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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