The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Automated Biochemical Analyzer (wak0-20r & 30r).
| Device ID | K912024 |
| 510k Number | K912024 |
| Device Name: | AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Ed Zior |
| Correspondent | Ed Zior WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-03 |
| Decision Date | 1991-07-19 |