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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 K801957
Device Name MICRO-FLOW SPECTROPHOTOMETER CL-720
Applicant
SHIMADZU PRECISION INSTRUMENTS, INC.
21010 SOUTH VERMONT AVE.
TORRANCE,  CA  90502
Correspondent
SHIMADZU PRECISION INSTRUMENTS, INC.
21010 SOUTH VERMONT AVE.
TORRANCE,  CA  90502
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/18/1980
Decision Date 09/26/1980
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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