The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Anti-tg Immunoassay, Elia Anti-tpo Immunoassay, Elia Thyroid Positive Control 250, Elia Thyroid Positive Control 2500/5000.
| Device ID | K151799 |
| 510k Number | K151799 |
| Device Name: | EliA Anti-TG Immunoassay, EliA Anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | PHADIA AB RAPSGATAN 7P Uppsala, SE Se 754 50 |
| Contact | Carina Magnusson |
| Correspondent | Martin Robert Mann PHADIA US INC. 4169 COMMERCIAL AVENUE Portage, MI 49002 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2016-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066015057 | K151799 | 000 |
| 07333066015040 | K151799 | 000 |
| 07333066014388 | K151799 | 000 |
| 07333066014371 | K151799 | 000 |
| 07333066014159 | K151799 | 000 |