Cleared Traditional

K013698 - AST (SGOT)
(FDA 510(k) Clearance)

K013698 · Jas Diagnostics, Inc. · Chemistry

Dec 2001

Decision

44d

Days

Class 2

Risk

K013698 is an FDA 510(k) clearance for the AST (SGOT), a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on December 21, 2001, 44 days after receiving the submission on November 7, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number	K013698 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2001
Decision Date	December 21, 2001
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement