IMMULITE® 2000 BR-MA
FDA 510(k) clearance K233946 · decided 2024-03-13
Clearance details
- K-number
- K233946
- Device name
- IMMULITE® 2000 BR-MA
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-14
- Decision date
- 2024-03-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MOI
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Llanberis, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.