IMMULITE 2500 OM-MA, MODEL L5KOP
FDA 510(k) clearance K072794 · decided 2007-11-05
Clearance details
- K-number
- K072794
- Device name
- IMMULITE 2500 OM-MA, MODEL L5KOP
- Applicant
- Siemens Medical Solutions Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-10-01
- Decision date
- 2007-11-05
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- LTK
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.