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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, Micro, For Clinical Use
510(k) Number K833804
Device Name SHABAN 9865 IL#78637 JUNCTION BLOC
Applicant
Shaban Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Shaban Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2170
Classification Product Code
JJF  
Date Received11/01/1983
Decision Date 01/13/1984
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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