Anti-Borrelia burgdorferi US Westernblot (IgG)
FDA 510(k) K161513 · Euroimmun US
510(k) numberK161513
Submission
- Device name
- Anti-Borrelia burgdorferi US Westernblot (IgG)
- Applicant
- Euroimmun US
Morris Plains, NJ, US - Received
- June 2, 2016
- Decision date
- August 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LSR – Reagent, Borrelia Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
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Questions and answers
When was Anti-Borrelia burgdorferi US Westernblot (IgG) cleared by the FDA?
Anti-Borrelia burgdorferi US Westernblot (IgG) (K161513) received a 510(k) decision of Substantially Equivalent on August 25, 2016, 84 days after the submission was received.
What is the product code of K161513?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.