Cleared Traditional

K895287 - VMA EIA KIT YAMASA
(FDA 510(k) Clearance)

K895287 · Yamasa Shoy Co., Ltd. · Chemistry

Oct 1989

Decision

66d

Days

Class 1

Risk

K895287 is an FDA 510(k) clearance for the VMA EIA KIT YAMASA. This device is classified as a Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (Class I — General Controls, product code CDF).

Submitted by Yamasa Shoy Co., Ltd. (Chuoku, Tokyo 103 Japan, JP). The FDA issued a Cleared decision on October 30, 1989, 66 days after receiving the submission on August 25, 1989.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1795.

Submission Details

510(k) Number	K895287 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 1989
Decision Date	October 30, 1989
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—