The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Igg-ha.
| Device ID | K923070 |
| 510k Number | K923070 |
| Device Name: | WAKO IGG-HA |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Edward Zior |
| Correspondent | Edward Zior WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1992-08-20 |