The following data is part of a De Novo classification by Wako Chemicals, Usa, Inc. with the FDA for Lba Afp-l3, Afp-l3 Calibrator Set, Afp-l3 Control Set And Libasys.
| DeNovo ID | DEN050002 |
| Device Name: | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS |
| Classification | Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 Bellwood Road Richmond, VA 23237 |
| Contact | Tonya Mallory |
| Product Code | NSF |
| CFR Regulation Number | 866.6030 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K041847 |
| Review Advisory Board | Immunology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2005-04-07 |
| Decision Date | 2005-05-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |