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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Phenobarbital
510(k) Number K843440
Device Name MINGO LOG 7
Applicant
Siemens Elema AB
Burditt, Bowles & Radzius
135 S. Lasalle St.
Chicago,  IL  60603 -
Applicant Contact JOSEPH R RADZIUS
Correspondent
Siemens Elema AB
Burditt, Bowles & Radzius
135 S. Lasalle St.
Chicago,  IL  60603 -
Correspondent Contact JOSEPH R RADZIUS
Regulation Number862.3660
Classification Product Code
DJH  
Date Received09/04/1984
Decision Date 09/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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