The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako(tm) Autokit Gamma-gt.
| Device ID | 113255 |
| 510k Number | K895984 |
| Device Name: | WAKO(TM) AUTOKIT GAMMA-GT |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Toshihiko Oda |
| Correspondent | Toshihiko Oda WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-13 |
| Decision Date | 1989-11-08 |