Cleared Traditional

K012163 - POLYTITER SYSTEM
(FDA 510(k) Clearance)

K012163 · Polymedco, Inc. · Immunology

Aug 2001

Decision

40d

Days

Class 2

Risk

K012163 is an FDA 510(k) clearance for the POLYTITER SYSTEM, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on August 20, 2001, 40 days after receiving the submission on July 11, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K012163 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2001
Decision Date	August 20, 2001
Days to Decision	40 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