COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL

Hemoglobin A2 Quantitation

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Columnmate Beta-thal Hba2 Control - Normal.

Pre-market Notification Details

Device IDK923318
510k NumberK923318
Device Name:COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
ClassificationHemoglobin A2 Quantitation
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPat Franks
CorrespondentPat Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeJPD  
CFR Regulation Number864.7400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-07
Decision Date1992-08-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.