IDS ACTH II
FDA 510(k) clearance K223867 · decided 2023-08-18
Clearance details
- K-number
- K223867
- Device name
- IDS ACTH II
- Applicant
- Immunodiagnostic Systems Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-12-23
- Decision date
- 2023-08-18
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- CKG
- Device class
- 2
- Regulation number
- 862.1025
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Boldon, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Immunodiagnostic Systems Limited
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.