Cleared Traditional

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

K944096 · Immuno Concepts, Inc. · Microbiology

Nov 1994

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K944096 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. (Irving, US). The FDA issued a Cleared decision on November 21, 1994, 91 days after receiving the submission on August 22, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K944096 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 1994
Decision Date	November 21, 1994
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
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