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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 K852262
Device Name ASSIST CLINICAL CHEMISTRY ANALYZER
Applicant
Cooper Biomedical, Inc.
One Technology Ct.
Malvern,  PA  19355
Applicant Contact DANIEL, PH.D.
Correspondent
Cooper Biomedical, Inc.
One Technology Ct.
Malvern,  PA  19355
Correspondent Contact DANIEL, PH.D.
Regulation Number862.2160
Classification Product Code
JJE  
Date Received05/24/1985
Decision Date 06/25/1985
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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