The following data is part of a premarket notification filed by Euroimmun Us with the FDA for 25-oh Vitamin D Elisa.
| Device ID | K123660 |
| 510k Number | K123660 |
| Device Name: | 25-OH VITAMIN D ELISA |
| Classification | System, Test, Vitamin D |
| Applicant | EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-28 |
| Decision Date | 2013-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016097129 | K123660 | 000 |