Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg
FDA 510(k) K032713 · Boston Biomedica, Inc.
510(k) numberK032713
Submission
- Device name
- Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg
- Applicant
- Boston Biomedica, Inc.
West Bridgewater, MA, US - Received
- September 2, 2003
- Decision date
- November 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSR – Reagent, Borrelia Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
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| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | Zeus Scientific | 07/13/2023SE |
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| 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 |
|---|---|---|
| K980351 | Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot KitLSR · Traditional | 03/05/1999SE |
| K974811 | Accurun(Tm) 150 HSV Igg Positive ControlJJX · Traditional | 02/10/1998SE |
| K974810 | Accurun(Tm) 132 Borrelia Burdorferi Igm Positive ControlLSR · Traditional | 02/05/1998SE |
| K974809 | Accurun(Tm) 130 Borrelia Burgdorferi Igg Positive ControlLSR · Traditional | 02/05/1998SE |
| K974261 | Accurun 135 Toxoplasma Igg Positive ControlLJK · Traditional | 12/11/1997SE |
| K972986 | Accurun 140 Rubella Igg Positive ControlMJX · Traditional | 10/08/1997SE |
| K972884 | Accurun 146 CMV Igm Positive ControlLKQ · Traditional | 08/22/1997SE |
| K972048 | Accurun 117 Hbeag Positive ControlJJY · Traditional | 08/12/1997SE |
| K971657 | Accurun 121 Hav Igm Positive ControlJJY · Traditional | 08/12/1997SE |
| K972307 | Accurun 119 Anti-Hepatitis B E Antigen (Anti-Hbe) Positive ControlJJY · Traditional | 08/07/1997SE |
Questions and answers
When was Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg cleared by the FDA?
Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg (K032713) received a 510(k) decision of Substantially Equivalent on November 24, 2003, 83 days after the submission was received.
What is the product code of K032713?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.