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.
Device ID | K123364 |
510k Number | K123364 |
Device Name: | 25OH VITAMIN D TOTAL ELISA TEST |
Classification | System, Test, Vitamin D |
Applicant | DIASOURCE IMMUNOASSAYS, S.A. 2851 SPAFFORD ST Davis, CA 95618 |
Contact | Napoleon Monce |
Correspondent | Napoleon Monce DIASOURCE IMMUNOASSAYS, S.A. 2851 SPAFFORD ST Davis, CA 95618 |
Product Code | MRG |
CFR Regulation Number | 862.1825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-01 |
Decision Date | 2013-07-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B2423825DHUE010 | K123364 | 000 |
30014613333951 | K123364 | 000 |
05400569000230 | K123364 | 000 |
00840239060877 | K123364 | 000 |
04048474060874 | K123364 | 000 |