The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Automated Reagents For Hitachi 705.
| Device ID | K842847 |
| 510k Number | K842847 |
| Device Name: | WAKO AUTOMATED REAGENTS FOR HITACHI 705 |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | WAKO CHEMICALS, USA, INC. 12200 FORD ROAD SUITE 212 Dallas , TX 75234 - |
| Contact | Hiroyuki Hayashi |
| Correspondent | Hiroyuki Hayashi WAKO CHEMICALS, USA, INC. 12200 FORD ROAD SUITE 212 Dallas , TX 75234 - |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-12-11 |