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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 K902689
Device Name ATAC 6000 CHEMISTRY ANALYZER
Applicant
Bio-Chem Laboratories
195 Lehigh Ave.
Lakewood,  NJ  08701
Applicant Contact JON D TURPEN
Correspondent
Bio-Chem Laboratories
195 Lehigh Ave.
Lakewood,  NJ  08701
Correspondent Contact JON D TURPEN
Regulation Number862.2160
Classification Product Code
JJE  
Date Received06/19/1990
Decision Date 07/10/1990
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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