The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit Lp(a) & Lp(a) Calibrator/cobas Bio.
| Device ID | K001933 |
| 510k Number | K001933 |
| Device Name: | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| 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 | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-26 |
| Decision Date | 2000-07-24 |