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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
510(k) Number K851154
Device Name ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18
Applicant
Astral Medical Systems
6900 Orangethorpe Ave.
Buena Park,  CA  90620
Applicant Contact THAD MORRIS
Correspondent
Astral Medical Systems
6900 Orangethorpe Ave.
Buena Park,  CA  90620
Correspondent Contact THAD MORRIS
Regulation Number862.2400
Classification Product Code
JQT  
Date Received03/22/1985
Decision Date 05/13/1985
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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