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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 K945271
Device Name ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM
Applicant
Bio-Chem Laboratory Systems, Inc.
195 Lehigh Ave.
Lakewood,  NJ  08701
Applicant Contact JON D TURPEN
Correspondent
Bio-Chem Laboratory Systems, Inc.
195 Lehigh Ave.
Lakewood,  NJ  08701
Correspondent Contact JON D TURPEN
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CEM   CGZ   CHH   CHL   JGS  
Date Received10/18/1994
Decision Date 04/20/1995
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
Recalls CDRH Recalls
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