SPIFE ALKALINE HEMOGLOBIN

System, Analysis, Electrophoretic Hemoglobin

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Alkaline Hemoglobin.

Pre-market Notification Details

Device IDK982426
510k NumberK982426
Device Name:SPIFE ALKALINE HEMOGLOBIN
ClassificationSystem, Analysis, Electrophoretic Hemoglobin
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 CodeJBD  
CFR Regulation Number864.7440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-13
Decision Date1998-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M5255527330 K982426 000

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