Eonis SCID-SMA Kit
FDA 510(k) clearance DEN200044 · decided 2022-11-09
Clearance details
- K-number
- DEN200044
- Device name
- Eonis SCID-SMA Kit
- Applicant
- Perkinelmer, Inc.
- Decision
- Unknown
- Date received
- 2020-07-08
- Decision date
- 2022-11-09
- Days to decision
- 854 days
- Clearance type
- Direct
- Product code
- QUE
- Device class
- 2
- Regulation number
- 866.5980
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Perkinelmer
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.