Cleared Traditional

K791597 - WAKO TRIGLYCERIDE
(FDA 510(k) Clearance)

K791597 · Wako Pure Chemical Industries, Ltd. · Chemistry

Sep 1979

Decision

33d

Days

Class 1

Risk

K791597 is an FDA 510(k) clearance for the WAKO TRIGLYCERIDE, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Wako Pure Chemical Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979, 33 days after receiving the submission on August 15, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number	K791597 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 1979
Decision Date	September 17, 1979
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—