The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako L-type Creatinine-m Test, And Wako Creatinine Calibrator.
Device ID | K061775 |
510k Number | K061775 |
Device Name: | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR |
Classification | Enzymatic Method, Creatinine |
Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
Contact | Lori Creasy |
Correspondent | Lori Creasy WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
Product Code | JFY |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-23 |
Decision Date | 2007-02-23 |
Summary: | summary |