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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K851321
Device Name ATAC 2000 CHEMISTRY ANALYZER
Applicant
Turpen Laboratory Systems, Inc.
P.O. Box 1148
W. County Line Rd.
Jackson,  NJ  08527
Applicant Contact JON D TURPEN
Correspondent
Turpen Laboratory Systems, Inc.
P.O. Box 1148
W. County Line Rd.
Jackson,  NJ  08527
Correspondent Contact JON D TURPEN
Regulation Number862.2100
Classification Product Code
JQP  
Date Received04/02/1985
Decision Date 04/25/1985
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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