Is Borrelia Burgdorferi Igg/Igm Elisa Test System
FDA 510(k) K983605 · Columbia Bioscience, Inc.
510(k) numberK983605
Submission
- Device name
- Is Borrelia Burgdorferi Igg/Igm Elisa Test System
- Applicant
- Columbia Bioscience, Inc.
Columbia, MD, US - Received
- October 14, 1998
- Decision date
- December 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
More from Gold Standard Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K991274 | Mumps Igg Elisa Test SystemLJY · Traditional | 09/03/1999SE |
| K990462 | Is H. Pylori Igg Elisa Test SystemLYR · Traditional | 09/03/1999SE |
| K984228 | Is Anti-Tpo Igg Elisa Test SystemJZO · Traditional | 02/02/1999SE |
| K983606 | Is Borrelia Burgdorferi Igm Test SystemLSR · Traditional | 12/16/1998SE |
| K983553 | Anti-Tg Igg Elisa Test SystemJZO · Traditional | 12/07/1998SE |
| K982352 | Vca Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982350 | Ea-D Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982348 | EBNA-1 Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K983740 | IS-ANTI-PR3 Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
| K983390 | Is-Anti-Mpo Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
Questions and answers
When was Is Borrelia Burgdorferi Igg/Igm Elisa Test System cleared by the FDA?
Is Borrelia Burgdorferi Igg/Igm Elisa Test System (K983605) received a 510(k) decision of Substantially Equivalent on December 16, 1998, 63 days after the submission was received.
What is the product code of K983605?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.