Cleared Traditional

LACTOFERRIN MICROASSAY SYSTEM

K934473 · Touch Scientific, Inc. · Immunology
Dec 1993
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K934473 is an FDA 510(k) clearance for the LACTOFERRIN MICROASSAY SYSTEM, a Lactoferrin, Antigen, Antiserum, Control (Class I — General Controls, product code DEG), submitted by Touch Scientific, Inc. (Raleigh, US). The FDA issued a Cleared decision on December 3, 1993, 80 days after receiving the submission on September 14, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5570.

Submission Details

510(k) Number K934473 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1993
Decision Date December 03, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DEG — Lactoferrin, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5570