FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IDS ACTH II
K Number: K223867
·
Decision Aug 18, 2023
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
29
Applicant Total
3
Review Days
238
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Basic Information
- Device Name
- IDS ACTH II
- K Number
- K223867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1025
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunodiagnostic Systems Limited
- Date Received
- December 23, 2022
- Decision Date
- August 18, 2023
- Product Code
- CKG
- 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 |
|---|---|---|---|
| CKG | Radioimmunoassay, Acth | FDA class 2 | Clinical Chemistry |
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