Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871
FDA 510(k) K062473 · DiaSorin, Inc.
510(k) numberK062473
Submission
- Device name
- Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- August 24, 2006
- Decision date
- April 12, 2007
- 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 Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871 cleared by the FDA?
Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871 (K062473) received a 510(k) decision of Substantially Equivalent on April 12, 2007, 231 days after the submission was received.
What is the product code of K062473?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.