IMMULITE® 2000 Cortisol
FDA 510(k) clearance K202826 · decided 2021-01-15
Clearance details
- K-number
- K202826
- Device name
- IMMULITE® 2000 Cortisol
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-24
- Decision date
- 2021-01-15
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- CGR
- Device class
- 2
- Regulation number
- 862.1205
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Caerarfon, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.