Cleared Traditional

K771068 - TRIGLYCERIDE KIT
(FDA 510(k) Clearance)

K771068 · Environmental Chemical Specialties · Chemistry

Jul 1977

Decision

29d

Days

Class 2

Risk

K771068 is an FDA 510(k) clearance for the TRIGLYCERIDE KIT. This device is classified as a Flame Photometry, Potassium (Class II — Special Controls, product code JGM).

Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on July 12, 1977, 29 days after receiving the submission on June 13, 1977.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number	K771068 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 1977
Decision Date	July 12, 1977
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—