Lyme-Spot If Kit
FDA 510(k) K910230 · Vitek Systems, Inc.
510(k) numberK910230
Submission
- Device name
- Lyme-Spot If Kit
- Applicant
- Vitek Systems, Inc.
Hazelwood, MI, US - Received
- January 18, 1991
- Decision date
- August 30, 1991
- 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 |
|---|---|---|
| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
| K921302 | Vitek Immunodiagnostic Assay SystemJHI · Traditional | 07/28/1992SE |
| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | 10/11/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
| K911429 | Vitek Gram Negative Identification Card, ModifiedLQM · Traditional | 06/24/1991SE |
Questions and answers
When was Lyme-Spot If Kit cleared by the FDA?
Lyme-Spot If Kit (K910230) received a 510(k) decision of Substantially Equivalent on August 30, 1991, 224 days after the submission was received.
What is the product code of K910230?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.