Cleared Traditional

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G

K013432 · Immuno Concepts, Inc. · Immunology
Nov 2001
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K013432 is an FDA 510(k) clearance for the IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G, a Anti-dna Indirect Immunofluorescent Solid Phase (Class II — Special Controls, product code KTL), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on November 29, 2001, 45 days after receiving the submission on October 15, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K013432 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2001
Decision Date November 29, 2001
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code KTL — Anti-dna Indirect Immunofluorescent Solid Phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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