Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)
FDA 510(k) K971007 · Mrl Diagnostics
510(k) numberK971007
Submission
- Device name
- Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)
- Applicant
- Mrl Diagnostics
Cypress, CA, US - Received
- March 19, 1997
- Decision date
- June 1, 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 |
|---|---|---|
| K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GLGC · Traditional | 04/14/2000SE |
| K993754 | HSV-1 Elisa Igg, Model EL0910GMXJ · Traditional | 02/09/2000SE |
| K993724 | HSV-2 Elisa Igg, Model EL0920GMYF · Traditional | 02/01/2000SE |
| K971006 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)LSR · Traditional | 06/01/1998SE |
| K946353 | Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayLLM · Traditional | 07/21/1995SE |
| K931520 | Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyLJN · Traditional | 04/26/1994SE |
Questions and answers
When was Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M) cleared by the FDA?
Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M) (K971007) received a 510(k) decision of Substantially Equivalent on June 1, 1998, 439 days after the submission was received.
What is the product code of K971007?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.