The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Lba Dcp Test System, Model 993-05301; Dcp Control Set, Model 995-0551; Dcp Calibrator Set, Libasys, Model 999-05401.
| Device ID | K062368 |
| 510k Number | K062368 |
| Device Name: | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 |
| Classification | Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Lori Creasy |
| Correspondent | Lori Creasy WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | OAU |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-14 |
| Decision Date | 2007-01-31 |
| Summary: | summary |