The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Crp, Calibrator And Wako Crp Calibrator Set.
Device ID | K024280 |
510k Number | K024280 |
Device Name: | WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET |
Classification | C-reactive Protein, Antigen, Antiserum, And 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 | DCK |
Subsequent Product Code | JIT |
Subsequent Product Code | JJK |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-23 |
Decision Date | 2003-06-06 |
Summary: | summary |