IVD CAPSULE PSP; abioSCOPE
FDA 510(k) clearance K240041 · decided 2024-09-25
Clearance details
- K-number
- K240041
- Device name
- IVD CAPSULE PSP; abioSCOPE
- Applicant
- Abionic SA
- Decision
- Substantially Equivalent
- Date received
- 2024-01-05
- Decision date
- 2024-09-25
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- SCX
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Epalinges, CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abionic SA
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.
Recalls involving this device
No recalls on record reference this clearance.