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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K895423
Device Name ACCESS CHEMISTRY ANALYZER
Applicant
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Applicant Contact JENNIFER LINE
Correspondent
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Correspondent Contact JENNIFER LINE
Regulation Number862.2160
Classification Product Code
JJE  
Date Received09/07/1989
Decision Date 10/04/1989
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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