Cleared Abbreviated

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

K030775 · Immuno Concepts, N.A. , Ltd. · Immunology
May 2003
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K030775 is an FDA 510(k) clearance for the AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Immuno Concepts, N.A. , Ltd. (Dallas, US). The FDA issued a Cleared decision on May 12, 2003, 62 days after receiving the submission on March 11, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K030775 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2003
Decision Date May 12, 2003
Days to Decision 62 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LKJ — Antinuclear Antibody, Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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