Immunodot Borrelia (Lyme) Test
FDA 510(k) K911627 · General Biometrics, Inc.
510(k) numberK911627
Submission
- Device name
- Immunodot Borrelia (Lyme) Test
- Applicant
- General Biometrics, Inc.
San Diego, CA, US - Received
- April 11, 1991
- Decision date
- April 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LSR – Reagent, Borrelia Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
Other 510(k)s with product code LSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIALSR · Traditional | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 07/10/2026SE |
| K252627 | Lyme-ID IgG Test; Bio-ID800LSR · Traditional | Inanovate, Inc. | 11/14/2025SE |
| K242872 | iDart Lyme IgM ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 06/12/2025SE |
| K233367 | iDart Lyme IgG ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 08/12/2024SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | Zeus Scientific | 07/13/2023SE |
| K220016 | Viramed Borrela All-In-One ViraChip Test KitLSR · Traditional | Viramed Biotech AG | 08/19/2022SE |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| 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 |
|---|---|---|
| K924843 | Immunodot(R) Ena/Dna Autoimmunity Screening PanelLLL · Traditional | 12/01/1992SE |
| K920401 | Immunowell Cardiolipin Antibody (Igm) TestMID · Traditional | 08/20/1992SE |
| K920400 | Immunowell Cardiolipin Antibody (Igg) TestMID · Traditional | 08/20/1992SE |
| K911599 | Immunowell Lyme (P39 Recombinant) TestLSR · Traditional | 12/30/1991SE |
| K911590 | Immunowell Borrelia (Lyme)TestLSR · Traditional | 12/20/1991SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | 12/09/1991SE |
| K911851 | Immunowell SM Antibody TestLKP · Traditional | 05/07/1991SE |
| K911850 | Immunwell Sjogren`S Syndrome B (la) Antibody TestLKO · Traditional | 05/07/1991SE |
| K911849 | Immunowell Sjogrens Syndrome a (Ro)Antibody TestLKO · Traditional | 05/07/1991SE |
| K911848 | Immunowell Rnp/Sm Antibody TestLKP · Traditional | 05/07/1991SE |
Questions and answers
When was Immunodot Borrelia (Lyme) Test cleared by the FDA?
Immunodot Borrelia (Lyme) Test (K911627) received a 510(k) decision of Substantially Equivalent on April 8, 1992, 363 days after the submission was received.
What is the product code of K911627?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.