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 |