CORNING 2500 CO-OXIMETER

Whole Blood Hemoglobin Determination

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 2500 Co-oximeter.

Pre-market Notification Details

Device IDK830590
510k NumberK830590
Device Name:CORNING 2500 CO-OXIMETER
ClassificationWhole Blood Hemoglobin Determination
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHG  
CFR Regulation Number864.7500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-24
Decision Date1983-04-05

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