STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM

System, Hemoglobin, Automated

STANBIO LABORATORY

The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System.

Pre-market Notification Details

Device IDK032482
510k NumberK032482
Device Name:STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
ClassificationSystem, Hemoglobin, Automated
Applicant STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne,  TX  78006
ContactKirk Johnson
CorrespondentKirk Johnson
STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne,  TX  78006
Product CodeGKR  
CFR Regulation Number864.5620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-12
Decision Date2003-10-24
Summary:summary

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