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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K772319
Device Name ANALYZER, CLINICAL, SYSTEM 3
Applicant
GILFORD INSTRUMENT LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GILFORD INSTRUMENT LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2160
Classification Product Code
JJE  
Date Received12/19/1977
Decision Date 01/12/1978
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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