ELECSYS RUBELLA IGG IMMUNOASSAY
FDA 510(k) clearance K072617 · decided 2008-12-05
Clearance details
- K-number
- K072617
- Device name
- ELECSYS RUBELLA IGG IMMUNOASSAY
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-17
- Decision date
- 2008-12-05
- Days to decision
- 445 days
- Clearance type
- Traditional
- Product code
- LFX
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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
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|---|---|---|
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| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |