Access anti-HAV IgM
FDA 510(k) clearance K251995 · decided 2026-01-27
Clearance details
- K-number
- K251995
- Device name
- Access anti-HAV IgM
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-27
- Decision date
- 2026-01-27
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- LOL
- Device class
- 2
- Regulation number
- 866.3310
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HAV IgM (K260048) | Roche Diagnostics | 2026-04-07 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| LIAISON Anti-HAV; LIAISON XS (K223403) | DiaSorin, Inc. | 2022-12-09 |
| LIAISON Anti-HAV (K210272) | DiaSorin, Inc. | 2021-02-09 |
| LIAISON Anti-HAV Assay (K193532) | DiaSorin, Inc. | 2020-03-02 |
| Elecsys Anti-HAV II (K190428) | Roche Diagnostics | 2019-08-13 |
| ADVIA Centaur HAV IgM Assay (K161964) | Siemens Healthcare Diagnostics, Inc. | 2016-10-13 |
| LIAISON HAV IgM, LIAISON Control HAV IgM (K160650) | DiaSorin, Inc. | 2016-08-25 |
| ADVIA Centaur HAV total assay (K142758) | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 |
| LIAISON XL ANALYZER (K141116) | DiaSorin, Inc. | 2014-07-25 |
| ARCHITECT HAVAB-G (K113704) | Abbott Laboratories | 2012-06-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |