FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IMMULITE® 2000 Cortisol
K Number: K202826
·
Decision Jan 15, 2021
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
4
Review Days
113
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IMMULITE® 2000 Cortisol
- K Number
- K202826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date Received
- September 24, 2020
- Decision Date
- January 15, 2021
- Product Code
- CGR
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGR), ordered by most recent decision date.
Access Cortisol; DxC 500i Clinical Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IDS Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMULITE/IMMULITE® 1000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CORTISOL ELISA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry