The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191.
Device ID | K053131 |
510k Number | K053131 |
Device Name: | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 |
Classification | Enzymatic Method, Bilirubin |
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 | JFM |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-08 |
Decision Date | 2005-12-30 |
Summary: | summary |