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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 K843059
Device Name ATAC 2000
Applicant
Turpen Laboratory Systems, Inc.
P{O. Box 1148
Jackson,  NJ  08527
Applicant Contact JON D TURPEN
Correspondent
Turpen Laboratory Systems, Inc.
P{O. Box 1148
Jackson,  NJ  08527
Correspondent Contact JON D TURPEN
Regulation Number862.2160
Classification Product Code
JJE  
Date Received08/03/1984
Decision Date 10/11/1984
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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