Borrelia Burgdorferi Igm Elisa Test System
FDA 510(k) K033070 · Trinity Biotech USA
510(k) numberK033070
Submission
- Device name
- Borrelia Burgdorferi Igm Elisa Test System
- Applicant
- Trinity Biotech USA
Jamestown, NY, US - Received
- September 29, 2003
- Decision date
- November 26, 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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| 510(k) | Device | Decision |
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| K033105 | Captia HSV 1 Igg Type Specific Elisa KitMXJ · Traditional | 07/13/2004SE |
| K033083 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033079 | Chlamydia Igg Elisa Test SystemLJC · Traditional | 11/26/2003SE |
| K033067 | Pylori IggLYR · Traditional | 11/26/2003SE |
| K033064 | Mycoplasma IggLON · Traditional | 11/26/2003SE |
| K033051 | Legionella Pneumophila Igg/IgmMJH · Traditional | 11/26/2003SE |
| K993839 | Ena Profile Elisa Test SystemLLL · Traditional | 01/12/2000SE |
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Questions and answers
When was Borrelia Burgdorferi Igm Elisa Test System cleared by the FDA?
Borrelia Burgdorferi Igm Elisa Test System (K033070) received a 510(k) decision of Substantially Equivalent on November 26, 2003, 58 days after the submission was received.
What is the product code of K033070?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.