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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 K843997
Device Name AO-10 AUTOMATED OSMOMETER
Applicant
bioMerieux, Inc.
Northhampton Industrial Park
75 Steam Whistle Dr.
Ivyland,  PA  18974
Applicant Contact WILLIAM A KOONTZ
Correspondent
bioMerieux, Inc.
Northhampton Industrial Park
75 Steam Whistle Dr.
Ivyland,  PA  18974
Correspondent Contact WILLIAM A KOONTZ
Regulation Number862.2730
Classification Product Code
JJM  
Date Received10/11/1984
Decision Date 10/31/1984
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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