The following data is part of a premarket notification filed by Yamasa Shoy Co., Ltd. with the FDA for Vma Eia Kit Yamasa.
Device ID | K895287 |
510k Number | K895287 |
Device Name: | VMA EIA KIT YAMASA |
Classification | Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
Applicant | YAMASA SHOY CO., LTD. 23-8 NIHONBASHI KAKIGARACHO 1-CHOME Chuoku, Tokyo 103 Japan, JP |
Contact | Jiro Sawada |
Correspondent | Jiro Sawada YAMASA SHOY CO., LTD. 23-8 NIHONBASHI KAKIGARACHO 1-CHOME Chuoku, Tokyo 103 Japan, JP |
Product Code | CDF |
CFR Regulation Number | 862.1795 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-25 |
Decision Date | 1989-10-30 |