Alkaline Phosphatase
FDA 510(k) clearance K240468 · decided 2024-10-16
Clearance details
- K-number
- K240468
- Device name
- Alkaline Phosphatase
- Applicant
- Abbott Laboratories Diagnostics Division
- Decision
- Substantially Equivalent
- Date received
- 2024-02-20
- Decision date
- 2024-10-16
- Days to decision
- 239 days
- Clearance type
- Special
- Product code
- CJE
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories Diagnostics Division
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.