HYDRAGEL 15 HB A1C KIT

Assay, Glycosylated Hemoglobin

MORAX

The following data is part of a premarket notification filed by Morax with the FDA for Hydragel 15 Hb A1c Kit.

Pre-market Notification Details

Device IDK963844
510k NumberK963844
Device Name:HYDRAGEL 15 HB A1C KIT
ClassificationAssay, Glycosylated Hemoglobin
Applicant MORAX 13805 WATERLOO RD. Chelsea,  MI  48118
ContactBorek Janik
CorrespondentBorek Janik
MORAX 13805 WATERLOO RD. Chelsea,  MI  48118
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-25
Decision Date1997-04-22

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