Skip to content

PolyTiter System

by Polymedco, Inc.

510(k) K012163

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012163 Date20 Aug 2001ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DHN
Device class
Class II
Regulation
21 CFR Part 866.5100
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PolyTiter System is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control device, classified under the Immunology category. It is designed for use in immunofluorescence assays to detect and quantify antinuclear antibodies (ANA) in serum or plasma samples, aiding in the diagnosis of autoimmune diseases such as systemic lupus erythematosus (SLE) and other connective tissue disorders.

This system is intended for laboratory use and is supplied as a single-use or reusable component set, depending on the specific antigen controls included. It operates under Class 2 regulatory classification (product code DHN) and has received FDA 510(k) clearance through the Traditional pathway. Sterility and handling instructions are detailed in the accompanying documentation, and proper storage conditions must be maintained to preserve functionality. The device is authorized under regulation number 866.5100 and is intended for use in accredited clinical laboratories.

Similar devices

Other devices filed under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control).

Other devices from Polymedco, Inc.

See all devices from Polymedco, Inc. →