Cleared Traditional

K844322 - SGOT REAGENT SET
(FDA 510(k) Clearance)

K844322 · Livonia Diagnostics, Inc. · Chemistry

Nov 1984

Decision

20d

Days

Class 2

Risk

K844322 is an FDA 510(k) clearance for the SGOT REAGENT SET. This device is classified as a Diazo, Ast/sgot (Class II — Special Controls, product code CIQ).

Submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on November 27, 1984, 20 days after receiving the submission on November 7, 1984.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number	K844322 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1984
Decision Date	November 27, 1984
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—