FDA Product Code
FDA Product Code PCA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2570
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | Life Technologies Corporation | 2020-02-21 | Traditional | PDF ↗ |
Product code PCA · Class II · Clinical Chemistry. Data: openFDA.