FDA Product Code
FDA Product Code QJE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1506
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN180056 | GSP Neonatal Creatine Kinase - MM kit | Perkinelmer, Inc. | 2019-12-12 | Direct | — |
Product code QJE · Class II · Clinical Chemistry. Data: openFDA.