GSP Neonatal Creatine Kinase - MM kit
FDA 510(k) clearance DEN180056 · decided 2019-12-12
Clearance details
- K-number
- DEN180056
- Device name
- GSP Neonatal Creatine Kinase - MM kit
- Applicant
- Perkinelmer, Inc.
- Decision
- Unknown
- Date received
- 2018-10-11
- Decision date
- 2019-12-12
- Days to decision
- 427 days
- Clearance type
- Direct
- Product code
- QJE
- Device class
- 2
- Regulation number
- 862.1506
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.