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Touch Tear Ige Microassay Kit

by Touch Scientific, Inc.

510(k) K991316

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991316 Date9 Aug 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
DGC
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Touch Tear Ige Microassay Kit is an in vitro diagnostic device used for the quantitative determination of Immunoglobulin E (IgE) concentration. It is classified as a Class 2 medical device. The device is associated with the medical specialty of Immunology.

The Touch Tear Ige Microassay Kit is supplied with an FDA 510(k) clearance, identified by the number K991316. The device has a product code of DGC and is regulated under the regulation number 866.5510. It was cleared by the FDA on August 9, 1999, after a 112-day review.

Other devices from Touch Scientific, Inc.

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Touch Tear Ige Microassay Kit used for?

    The Touch Tear Ige Microassay Kit is used for the quantitative determination of Immunoglobulin E (IgE) concentration in vitro.

  • Is the Touch Tear Ige Microassay Kit supplied sterile?

    The device data does not specify if the kit is supplied sterile, but it is intended for in vitro diagnostic use.

  • What is the regulatory classification of the Touch Tear Ige Microassay Kit?

    The Touch Tear Ige Microassay Kit is classified as a Class 2 medical device and is regulated under the regulation number 866.5510.

  • What is the product code of the Touch Tear Ige Microassay Kit?

    The product code of the Touch Tear Ige Microassay Kit is DGC.