Cleared Traditional

RELSIA SCL-70 ANTIBODY TEST SYSTEM

K955602 · Immuno Concepts, Inc. · Immunology
Apr 1996
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K955602 is an FDA 510(k) clearance for the RELSIA SCL-70 ANTIBODY TEST SYSTEM, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on April 19, 1996, 133 days after receiving the submission on December 8, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K955602 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1995
Decision Date April 19, 1996
Days to Decision 133 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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

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