25OH VITAMIN D TOTAL ELISA TEST

System, Test, Vitamin D

DIASOURCE IMMUNOASSAYS, S.A.

The following data is part of a premarket notification filed by Diasource Immunoassays, S.a. with the FDA for 25oh Vitamin D Total Elisa Test.

Pre-market Notification Details

Device IDK123364
510k NumberK123364
Device Name:25OH VITAMIN D TOTAL ELISA TEST
ClassificationSystem, Test, Vitamin D
Applicant DIASOURCE IMMUNOASSAYS, S.A. 2851 SPAFFORD ST Davis,  CA  95618
ContactNapoleon Monce
CorrespondentNapoleon Monce
DIASOURCE IMMUNOASSAYS, S.A. 2851 SPAFFORD ST Davis,  CA  95618
Product CodeMRG  
CFR Regulation Number862.1825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-01
Decision Date2013-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B2423825DHUE010 K123364 000
30014613333951 K123364 000
05400569000230 K123364 000
00840239060877 K123364 000
04048474060874 K123364 000

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