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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 K853699
Device Name EASY ANALYZER & EASY-TEST REAGENT
Applicant
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.2160
Classification Product Code
JJE  
Date Received09/04/1985
Decision Date 09/25/1985
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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