The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako(tm) Igm-ha Direct.
| Device ID | K880828 |
| 510k Number | K880828 |
| Device Name: | WAKO(TM) IGM-HA DIRECT |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
| Contact | Toshihiko Oda |
| Correspondent | Toshihiko Oda WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-03-25 |