Platelia Lyme Igg Assay
FDA 510(k) K080012 · Bio-Rad
510(k) numberK080012
Submission
- Device name
- Platelia Lyme Igg Assay
- Applicant
- Bio-Rad
Beverly, MA, US - Received
- January 3, 2008
- Decision date
- May 8, 2008
- 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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Questions and answers
When was Platelia Lyme Igg Assay cleared by the FDA?
Platelia Lyme Igg Assay (K080012) received a 510(k) decision of Substantially Equivalent on May 8, 2008, 126 days after the submission was received.
What is the product code of K080012?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.