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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 K822720
Device Name MODEL 340 SPECTROPHOTOMETER
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/07/1982
Decision Date 10/08/1982
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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