FDA 510(k), K113830, VANTERA CLINICAL ANALYZER
FDA 510(k), K113830, VANTERA CLINICAL ANALYZER
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510(K) Number: K113830
Device Name: VANTERA CLINICAL ANALYZER
Manufacturer: LIPOSCIENCE
Device Classification Name: lipase hydrolysis/glycerol kinase enzyme, triglycerides
Regulation Number: 862.1705
Classification Product Code: CDT
Date Received: 12/27/2011
Decision Date: 08/30/2012
Regulation Medical Specialty: Clinical Chemistry
Device Name: VANTERA CLINICAL ANALYZER
Manufacturer: LIPOSCIENCE
Device Classification Name: lipase hydrolysis/glycerol kinase enzyme, triglycerides
Regulation Number: 862.1705
Classification Product Code: CDT
Date Received: 12/27/2011
Decision Date: 08/30/2012
Regulation Medical Specialty: Clinical Chemistry