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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 K851572
Device Name NOVASPEC VISIBLE SPECTROPHOTOMETER
Applicant
LKB INSTRUMENTS, INC.
9319 GAITHER RD.
GAITHERSBURG,  MD  20877
Applicant Contact ED ZIOR
Correspondent
LKB INSTRUMENTS, INC.
9319 GAITHER RD.
GAITHERSBURG,  MD  20877
Correspondent Contact ED ZIOR
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received04/17/1985
Decision Date 05/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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