FDA 510(k) Application Details - K843440

Device Classification Name Gas Chromatography, Phenobarbital

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510(K) Number K843440
Device Name Gas Chromatography, Phenobarbital
Applicant SIEMENS ELEMA AB
BURDITT, BOWLES & RADZIUS
135 SOUTH LASALLE STREET
CHICAGO, IL US
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Contact JOSEPH R RADZIUS
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Regulation Number 862.3660

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Classification Product Code DJH
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Date Received 09/04/1984
Decision Date 09/04/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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