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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 K944185
Device Name ISOSCAN
Applicant
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Applicant Contact JANET D PERKINS
Correspondent
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Correspondent Contact JANET D PERKINS
Regulation Number862.2400
Classification Product Code
JQT  
Date Received08/26/1994
Decision Date 11/17/1994
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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