Lyme Igm Elisa Test
FDA 510(k) K903013 · Gull Laboratories, Inc.
510(k) numberK903013
Submission
- Device name
- Lyme Igm Elisa Test
- Applicant
- Gull Laboratories, Inc.
Salt Lake City, UT, US - Received
- July 11, 1990
- Decision date
- June 21, 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 |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | 11/04/1997SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Lyme Igm Elisa Test cleared by the FDA?
Lyme Igm Elisa Test (K903013) received a 510(k) decision of Substantially Equivalent on June 21, 1991, 345 days after the submission was received.
What is the product code of K903013?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.