NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

Enzymatic Methods, Galactose

WALLAC OY

The following data is part of a premarket notification filed by Wallac Oy with the FDA for Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 And 3029-110b.

Pre-market Notification Details

Device IDK071649
510k NumberK071649
Device Name:NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
ClassificationEnzymatic Methods, Galactose
Applicant WALLAC OY 940 WINTER STREET Waltham,  MA  02451
ContactCindy Lloyd
CorrespondentCindy Lloyd
WALLAC OY 940 WINTER STREET Waltham,  MA  02451
Product CodeJIA  
CFR Regulation Number862.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-18
Decision Date2008-08-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147275281 K071649 000

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