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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K862908
Device Name AKERSCAN COLORIMETRIC ANALYZER
Applicant
Akers Medical Technologies
P.O. Box 2958
26 Springdale Rd.
Cherry Hill,  NJ  08034
Applicant Contact RAYMOND AKERS,JR,PHD
Correspondent
Akers Medical Technologies
P.O. Box 2958
26 Springdale Rd.
Cherry Hill,  NJ  08034
Correspondent Contact RAYMOND AKERS,JR,PHD
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/31/1986
Decision Date 09/15/1986
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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