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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 K850260
Device Name GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER
Applicant
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Applicant Contact HARWOOD GREEN
Correspondent
Gelman Sciences, Inc.
600 S Wagner Rd.
Ann Arbor,  MI  48103
Correspondent Contact HARWOOD GREEN
Regulation Number862.2400
Classification Product Code
JQT  
Date Received01/22/1985
Decision Date 02/27/1985
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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