Cleared Traditional

K880628 - TRIGLYCERIDES (GPO-TRINDER)
(FDA 510(k) Clearance)

K880628 · Tech-Co, Inc. · Chemistry

Mar 1988

Decision

28d

Days

Class 1

Risk

K880628 is an FDA 510(k) clearance for the TRIGLYCERIDES (GPO-TRINDER), a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on March 15, 1988, 28 days after receiving the submission on February 16, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number	K880628 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 1988
Decision Date	March 15, 1988
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—