Cleared Traditional

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

K972145 · Immuno Concepts, Inc. · Immunology

Feb 1998

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K972145 is an FDA 510(k) clearance for the HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM, 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 February 24, 1998, 263 days after receiving the submission on June 6, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K972145 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 1997
Decision Date	February 24, 1998
Days to Decision	263 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