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 |