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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 K772325
Device Name DENSITOMETER 18, COMPUTING, AUTO.
Applicant
Gelman Instrument Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gelman Instrument Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2400
Classification Product Code
JQT  
Date Received12/19/1977
Decision Date 01/12/1978
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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