CENTRIFICHEM BUN

Urease And Glutamic Dehydrogenase, Urea Nitrogen

UNION CARBIDE CORP.

The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centrifichem Bun.

Pre-market Notification Details

Device IDK800529
510k NumberK800529
Device Name:CENTRIFICHEM BUN
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-07
Decision Date1980-03-20

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