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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K934124
Device Name AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
Applicant
Andronic Devices, Ltd.
Suite 140
13120 Vanier Pl.
Richmond, B.C. Canada V6v 2j2,  CA V6V 2J2
Applicant Contact ROBERT MACNIEL
Correspondent
Andronic Devices, Ltd.
Suite 140
13120 Vanier Pl.
Richmond, B.C. Canada V6v 2j2,  CA V6V 2J2
Correspondent Contact ROBERT MACNIEL
Regulation Number862.2750
Classification Product Code
JQW  
Date Received08/25/1993
Decision Date 04/13/1994
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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