The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako-igg Ii-ha, Immunoglobulin Calibrator Set, Immunolobulin Standard.
| Device ID | K993928 |
| 510k Number | K993928 |
| Device Name: | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Tanya Mallory |
| Correspondent | Tanya Mallory WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-18 |
| Decision Date | 2000-01-18 |
| Summary: | summary |