Cleared Traditional

HVA EIA KIT YAMASA

K895288 · Yamasa Shoy Co., Ltd. · Chemistry

Oct 1989

Decision

67d

Days

Class 1

Risk

About This 510(k) Submission

K895288 is an FDA 510(k) clearance for the HVA EIA KIT YAMASA, 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 31, 1989, 67 days after receiving the submission on August 25, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1795.

Submission Details

510(k) Number	K895288 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 1989
Decision Date	October 31, 1989
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—