The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Rf-ha (2), Rf Calibrator, Rf Calibrator Set.
| Device ID | K020972 |
| 510k Number | K020972 |
| Device Name: | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-26 |
| Decision Date | 2002-09-09 |
| Summary: | summary |