The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Anti-borrelia Burgdorferi Us Westernblot (igg).
| Device ID | K161513 |
| 510k Number | K161513 |
| Device Name: | Anti-Borrelia Burgdorferi US Westernblot (IgG) |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Michael Locke |
| Correspondent | Michael Locke EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016126010 | K161513 | 000 |
| 04049016126003 | K161513 | 000 |