Monolisa Anti-Hav Eia
FDA 510(k) K063318 · Bio-Rad Laboratories
510(k) numberK063318
Submission
- Device name
- Monolisa Anti-Hav Eia
- Applicant
- Bio-Rad Laboratories
Hauts-De-Seine, FR - Received
- November 2, 2006
- Decision date
- May 3, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOL – Hepatitis A Test (Antibody And Igm Antibody)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3310
- Specialty
- Microbiology
Other 510(k)s with product code LOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | Roche Diagnostics | 04/07/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | Beckman Coulter, Inc. | 01/27/2026SE |
| K243846 | Access anti-HAVLOL · Traditional | Beckman Coulter, Inc. | 09/09/2025SE |
| K222850 | HAVAb IgG IILOL · Traditional | Abbott Laboratories | 08/10/2023SE |
| K223403 | LIAISON Anti-HAV; LIAISON XSLOL · Special | DiaSorin, Inc. | 12/09/2022SE |
| K210272 | LIAISON Anti-HAVLOL · Special | DiaSorin, Inc. | 02/09/2021SE |
| K193532 | LIAISON Anti-HAV AssayLOL · Traditional | DiaSorin, Inc. | 03/02/2020SE |
| K190428 | Elecsys Anti-HAV IILOL · Traditional | Roche Diagnostics | 08/13/2019SE |
| K161964 | ADVIA Centaur HAV IgM AssayLOL · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/13/2016SE |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgMLOL · Traditional | DiaSorin, Inc. | 08/25/2016SE |
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Questions and answers
When was Monolisa Anti-Hav Eia cleared by the FDA?
Monolisa Anti-Hav Eia (K063318) received a 510(k) decision of Substantially Equivalent on May 3, 2007, 182 days after the submission was received.
What is the product code of K063318?
The FDA product code is LOL – Hepatitis A Test (Antibody And Igm Antibody), a Class II (moderate risk) device regulated under 21 CFR 866.3310.