Lyme Disease Ifa (Igg)
FDA 510(k) K883487 · Hillcrest Biologicals
510(k) numberK883487
Submission
- Device name
- Lyme Disease Ifa (Igg)
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- August 16, 1988
- Decision date
- December 13, 1988
- 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 |
|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | 12/03/1992SE |
| K913617 | Arbovirus Igg Ifa TestGQC · Traditional | 12/03/1992SE |
| K922374 | Q Fever Igm Ifa TestGPJ · Traditional | 10/21/1992SE |
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | 10/21/1992SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | 06/28/1991SE |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | 01/16/1990SE |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | 01/24/1989SE |
| K875170 | Ebna AntibodyLLM · Traditional | 05/23/1988SE |
Questions and answers
When was Lyme Disease Ifa (Igg) cleared by the FDA?
Lyme Disease Ifa (Igg) (K883487) received a 510(k) decision of Substantially Equivalent on December 13, 1988, 119 days after the submission was received.
What is the product code of K883487?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.