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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 K870836
Device Name ATAC 1500 CHEMISTRY ANALYZER
Applicant
Turpen Laboratory Systems, Inc.
1650 Oak St.
Lakewood,  NJ  08701
Applicant Contact JON D TURPEN
Correspondent
Turpen Laboratory Systems, Inc.
1650 Oak St.
Lakewood,  NJ  08701
Correspondent Contact JON D TURPEN
Regulation Number862.2160
Classification Product Code
JJE  
Date Received03/03/1987
Decision Date 04/01/1987
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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