The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Igm Ii- Ha, Immunolobulin Calibrator Set, Immunolobulin Standard.
| Device ID | K993924 |
| 510k Number | K993924 |
| Device Name: | WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Tonya Mallory |
| Correspondent | Tonya Mallory 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 | 1999-11-18 |
| Decision Date | 2000-01-14 |
| Summary: | summary |