Athena Multi-Lyte Borrelia VLSE-1/PEPC10 Plus Test System
FDA 510(k) K100728 · Zeus Scientific, Inc.
510(k) numberK100728
Submission
- Device name
- Athena Multi-Lyte Borrelia VLSE-1/PEPC10 Plus Test System
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- March 15, 2010
- Decision date
- July 6, 2010
- 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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| 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 Athena Multi-Lyte Borrelia VLSE-1/PEPC10 Plus Test System cleared by the FDA?
Athena Multi-Lyte Borrelia VLSE-1/PEPC10 Plus Test System (K100728) received a 510(k) decision of Substantially Equivalent on July 6, 2010, 113 days after the submission was received.
What is the product code of K100728?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.