The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit Micro Tp.
| Device ID | K920531 |
| 510k Number | K920531 |
| Device Name: | WAKO AUTOKIT MICRO TP |
| Classification | Biuret (colorimetric), Total Protein |
| 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 | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-05 |
| Decision Date | 1992-07-14 |