The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako L-type Got Test.
Device ID | K993468 |
510k Number | K993468 |
Device Name: | WAKO L-TYPE GOT TEST |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
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 | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-13 |
Decision Date | 1999-12-16 |
Summary: | summary |