Cleared Traditional

ACCESS R-CLONE ANA PROFILE ASSAY

K885048 · Lipogen, Inc. · Immunology
Jan 1989
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K885048 is an FDA 510(k) clearance for the ACCESS R-CLONE ANA PROFILE ASSAY, a System, Test, Systemic Lupus Erythematosus (Class II — Special Controls, product code DHC), submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on January 24, 1989, 48 days after receiving the submission on December 7, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5820.

Submission Details

510(k) Number K885048 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1988
Decision Date January 24, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DHC — System, Test, Systemic Lupus Erythematosus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5820

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