Cleared Traditional

HEP-2000 COLORZYME ANA-RO TEST SYSTEM

K950979 · Immuno Concepts, Inc. · Immunology

Jun 1995

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K950979 is an FDA 510(k) clearance for the HEP-2000 COLORZYME ANA-RO TEST SYSTEM, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Immuno Concepts, Inc. (Irving, US). The FDA issued a Cleared decision on June 1, 1995, 90 days after receiving the submission on March 3, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K950979 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 1995
Decision Date	June 01, 1995
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

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