FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IDS Cortisol
K Number: K202136
·
Decision Apr 13, 2021
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
23
Review Days
256
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Basic Information
- Device Name
- IDS Cortisol
- K Number
- K202136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunodiagnostic Systems , Ltd.
- Date Received
- July 31, 2020
- Decision Date
- April 13, 2021
- Product Code
- CGR
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
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