FDA Product Code
FDA Product Code NSF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6030
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION | Wako Chemicals USA, Inc. | 2011-02-23 | Traditional | PDF ↗ |
| DEN050002 | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS | Wako Chemicals USA, Inc. | 2005-05-19 | Post-NSE | — |
Product code NSF · Class II · Immunology. Data: openFDA.