LIAISON HAV IgM, LIAISON Control HAV IgM
FDA 510(k) K160650 · DiaSorin, Inc.
510(k) numberK160650
Submission
- Device name
- LIAISON HAV IgM, LIAISON Control HAV IgM
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- March 8, 2016
- Decision date
- August 25, 2016
- 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 |
| K142758 | ADVIA Centaur HAV total assayLOL · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/05/2014SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXLOM · Traditional | 06/04/2026SE |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY · Traditional | 10/27/2023SE |
| K223403 | LIAISON Anti-HAV; LIAISON XSLOL · Special | 12/09/2022SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | 07/26/2022SE |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS · Traditional | 07/14/2022SE |
| K193650 | LIAISON FerritinDBF · Traditional | 09/14/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K210272 | LIAISON Anti-HAVLOL · Special | 02/09/2021SE |
| K201908 | LIAISON Testosterone xtCDZ · Special | 10/15/2020SE |
Questions and answers
When was LIAISON HAV IgM, LIAISON Control HAV IgM cleared by the FDA?
LIAISON HAV IgM, LIAISON Control HAV IgM (K160650) received a 510(k) decision of Substantially Equivalent on August 25, 2016, 170 days after the submission was received.
What is the product code of K160650?
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.