FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K Number: K203296
·
Decision Mar 22, 2021
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
14
Review Days
133
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Basic Information
- Device Name
- Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K Number
- K203296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gold Standard Diagnostics
- Date Received
- November 9, 2020
- Decision Date
- March 22, 2021
- Product Code
- LSR
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
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Other Clearances by Gold Standard Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | Mar 22, 2021 | Substantially Equivalent |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Mar 22, 2021 | Substantially Equivalent |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Mar 22, 2021 | Substantially Equivalent |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Apr 6, 2020 | Substantially Equivalent |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Apr 6, 2020 | Substantially Equivalent |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | May 2, 2018 | Substantially Equivalent |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Nov 12, 2015 | Substantially Equivalent |
| K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | Feb 28, 2014 | Substantially Equivalent |
| K131330 | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | Jan 28, 2014 | Substantially Equivalent |
| K113846 | BORRELIA BURGDORFERI IGM BLOT TEST | Jun 1, 2012 | Substantially Equivalent |