The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Apolipoprotein High Level Calibrator.
| Device ID | K001004 |
| 510k Number | K001004 |
| Device Name: | WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR |
| Classification | Calibrator, Primary |
| 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 | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-29 |
| Decision Date | 2000-06-01 |