Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
FDA 510(k) clearance K250983 · decided 2026-01-30
Clearance details
- K-number
- K250983
- Device name
- Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
- Applicant
- Asistan Medikal
- Decision
- Substantially Equivalent
- Date received
- 2025-03-31
- Decision date
- 2026-01-30
- Days to decision
- 305 days
- Clearance type
- Traditional
- Product code
- SCL
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Oguzeli, Gaziantep, TR
- Third-party review
- No
- Expedited review
- No
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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.