FDA Product Code
FDA Product Code KWX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1187
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993941 | UBAS | Marukin Diagnostics | 2000-03-02 | Traditional | PDF ↗ |
| K980525 | UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD | Marukin Shoyu Co., Ltd. | 1998-04-15 | Traditional | PDF ↗ |
Product code KWX · Class II · Clinical Chemistry. Data: openFDA.