FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Access anti-HBc Total
K Number: K253687
·
Decision Feb 19, 2026
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
3
Applicant Total
270
Review Days
90
Basic Information
- Device Name
- Access anti-HBc Total
- K Number
- K253687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3173
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- November 21, 2025
- Decision Date
- February 19, 2026
- Product Code
- SEI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SEI), ordered by most recent decision date.
Elecsys Anti-HBc IgM
FDA 510(k)
FDA Class 2
·Microbiology
Elecsys Anti-HBc II
FDA 510(k)
FDA Class 2
·Microbiology
Access anti-HBc IgM
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Beckman Coulter, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252169 | Access BNP II | Mar 24, 2026 | Substantially Equivalent |
| K254059 | Access anti-HBc IgM | Mar 13, 2026 | Substantially Equivalent |
| K251995 | Access anti-HAV IgM | Jan 27, 2026 | Substantially Equivalent |
| K250588 | Access Rubella IgG | Nov 17, 2025 | Substantially Equivalent |
| K252580 | iQ200 Series | Sep 10, 2025 | Substantially Equivalent |
| K243846 | Access anti-HAV | Sep 9, 2025 | Substantially Equivalent |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | Aug 20, 2025 | Substantially Equivalent |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Aug 15, 2025 | Substantially Equivalent |
| K243483 | Access hsTnI | Aug 1, 2025 | Substantially Equivalent |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Jul 18, 2025 | Substantially Equivalent |