Sulopenem SPM 2 µg
FDA 510(k) clearance K251879 · decided 2025-08-12
Clearance details
- K-number
- K251879
- Device name
- Sulopenem SPM 2 µg
- Applicant
- Liofilchem
- Decision
- Substantially Equivalent
- Date received
- 2025-06-18
- Decision date
- 2025-08-12
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.