TOTAL GALACTOSE

Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase

ALPKEM CORP.

The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Total Galactose.

Pre-market Notification Details

Device IDK894011
510k NumberK894011
Device Name:TOTAL GALACTOSE
ClassificationFluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Applicant ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
ContactRaymond L Pavitt
CorrespondentRaymond L Pavitt
ALPKEM CORP. BOX 1260 Clackamas,  OR  97015
Product CodeKQP  
CFR Regulation Number862.1315 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-06
Decision Date1990-01-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00725609000014 K894011 000

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