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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flame Emission Photometer For Clinical Use
510(k) Number K771337
Device Name I.L. MODEL 643 FLAME PHOTOMETER
Applicant
INSTRUMENTATION LABORATORY CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSTRUMENTATION LABORATORY CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2540
Classification Product Code
JJO  
Date Received07/19/1977
Decision Date 10/18/1977
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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