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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 K780083
Device Name ANALYZER, SELECTIVE, ELECTRONIC
Applicant
JOHNS SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JOHNS SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2160
Classification Product Code
JJE  
Date Received01/16/1978
Decision Date 03/09/1978
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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