510(k) K163695
- Device
- Borrelia B31 ViraChip IgM Test Kit
- Applicant
- Viramed Biotech AG
- 510(k) number
- K163695
- Product code
- LSR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-22
- Date received
- 2016-12-28
- Regulation
- 866.3830
- Classification name
- Reagent, Borrelia Serological Reagent
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Martin Kintrup
- Address
- Behringstrasse 11 Planegg DE 82152 82152
FDA Registration Numbers#
- 3032705
- 3006198300
- 3002800697
- 3042641161
- 2020808
- 3005360469
- 3021090658
- 3003030793
- 3003268355
- 3002792284
- 3004973408
- 9615037
- 2245285
- 2915274
- 2182595
- 3007118747
- 1318354
- 3007361513
- 3004181478
- 3008191245
- 2242436
- 3015376545
- 3033751096
- 2024674
- 3033507883
- 2029372
- 1419968
- 2027113
- 3007208259
- 8020790
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LSR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | 2025-11-14 |
| K242872 | iDart Lyme IgM ImmunoBlot Kit | Id-Fish Technology, Inc. | 2025-06-12 |
| K233367 | iDart Lyme IgG ImmunoBlot Kit | Id-Fish Technology, Inc. | 2024-08-12 |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | Zeus Scientific | 2023-07-13 |
| K220016 | Viramed Borrela All-In-One ViraChip Test Kit | Viramed Biotech AG | 2022-08-19 |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | 2021-03-22 |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | 2021-02-18 |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | 2021-02-18 |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | 2020-04-06 |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | 2020-04-06 |
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | DiaSorin, Inc. | 2020-01-29 |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Zeus Scientific, Inc. | 2019-07-29 |
Legacy Summary#
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FDA Review#
Decision Summary