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/beckman Cx.
Device ID | K001934 |
510k Number | K001934 |
Device Name: | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX |
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 |