FDA Product Code
FDA Product Code PFT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.3800
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN130042 | MISEQDX UNIVERSAL KIT 1.0 | Illumina, Inc. | 2013-11-19 | Direct | — |
Product code PFT · Class I · Clinical Chemistry. Data: openFDA.