Cleared Traditional

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L

K011068 · Rhigene, Inc. · Immunology
Apr 2002
Decision
367d
Days
Class 2
Risk

About This 510(k) Submission

K011068 is an FDA 510(k) clearance for the RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L, a Anti-dna Indirect Immunofluorescent Solid Phase (Class II — Special Controls, product code KTL), submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on April 11, 2002, 367 days after receiving the submission on April 9, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K011068 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2001
Decision Date April 11, 2002
Days to Decision 367 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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