Cleared Traditional

LACTOCARD

K931901 · Touch Scientific, Inc. · Immunology
Jul 1993
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K931901 is an FDA 510(k) clearance for the LACTOCARD, 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 July 6, 1993, 78 days after receiving the submission on April 19, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5570.

Submission Details

510(k) Number K931901 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1993
Decision Date July 06, 1993
Days to Decision 78 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