Cleared Traditional

HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO

K983924 · Immuno Concepts, Inc. · Immunology

Dec 1998

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K983924 is an FDA 510(k) clearance for the HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 18, 1998, 44 days after receiving the submission on November 4, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K983924 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 1998
Decision Date	December 18, 1998
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

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