Cleared Traditional

K961114 - AST INCORPORATING DST
(FDA 510(k) Clearance)

K961114 · Trace Scientific , Ltd. · Chemistry

May 1996

Decision

64d

Days

Class 2

Risk

K961114 is an FDA 510(k) clearance for the AST INCORPORATING DST. This device is classified as a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT).

Submitted by Trace Scientific , Ltd. (Miami, US). The FDA issued a Cleared decision on May 23, 1996, 64 days after receiving the submission on March 20, 1996.

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

Submission Details

510(k) Number	K961114 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 1996
Decision Date	May 23, 1996
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement