COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL

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-abnormal.

Pre-market Notification Details

Device IDK923317
510k NumberK923317
Device Name:COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
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

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