The following data is part of a premarket notification filed by Euroimmun Us, Inc. with the FDA for Anti-borrelia Burgdorferi Us Euroline-wb (igm).
| Device ID | K172722 |
| 510k Number | K172722 |
| Device Name: | Anti-Borrelia Burgdorferi US EUROLINE-WB (IgM) |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | EUROIMMUN US, Inc. 1 Bloomfield Ave. Mountain Lakes, NJ 07046 |
| Contact | Michael A. Locke |
| Correspondent | Michael A. Locke EUROIMMUN US, Inc. 1 Bloomfield Ave. Mountain Lakes, NJ 07046 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-11 |
| Decision Date | 2017-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016134992 | K172722 | 000 |
| 04049016134985 | K172722 | 000 |