ELECSYSCA 15-3 II ASSAY
FDA 510(k) clearance K010588 · decided 2001-03-28
Clearance details
- K-number
- K010588
- Device name
- ELECSYSCA 15-3 II ASSAY
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-27
- Decision date
- 2001-03-28
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MOI
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
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| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |