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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 K811840
Device Name BILIRUBINOMETER
Applicant
Advanced Instruments, Inc.
Shorashim
Correspondent
Advanced Instruments, Inc.
Shorashim
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/01/1981
Decision Date 07/15/1981
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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