Bion Borrelia Burgdorferi Antigen Substrate Slide
FDA 510(k) K901054 · Bion Ent., Ltd.
510(k) numberK901054
Submission
- Device name
- Bion Borrelia Burgdorferi Antigen Substrate Slide
- Applicant
- Bion Ent., Ltd.
Park Ridge, IL, US - Received
- March 6, 1990
- Decision date
- April 5, 1990
- 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
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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 |
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Questions and answers
When was Bion Borrelia Burgdorferi Antigen Substrate Slide cleared by the FDA?
Bion Borrelia Burgdorferi Antigen Substrate Slide (K901054) received a 510(k) decision of Substantially Equivalent on April 5, 1990, 30 days after the submission was received.
What is the product code of K901054?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.