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Syringe for Blood Sampling

by The University of Chicago

510(k) K803182

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK803182 Date16 Jan 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GIM
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Syringe for Blood Sampling is a medical device designed for collecting blood specimens. It is classified under device code GIM and is intended for use in clinical chemistry applications.

This device is supplied as a single-use item and is not MRI compatible. It is regulated under FDA 510K clearance with decision code SESE and is classified as Class II. The device is stored at room temperature and requires no special handling beyond standard medical device protocols.

Other devices from The University of Chicago

Questions

AI-generated answers, 24 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 Syringe for Blood Sampling used for?

    The Syringe for Blood Sampling is designed specifically for collecting blood specimens in clinical chemistry applications. It is classified under device code GIM and is intended for laboratory diagnostic procedures.

  • Is the Syringe for Blood Sampling reusable or single-use?

    This device is supplied as a single-use item and should not be reused for patient safety reasons. It requires no special handling beyond standard medical device protocols and is stored at room temperature.

  • What is the regulatory classification of this blood sampling syringe?

    The Syringe for Blood Sampling is regulated under FDA 510K clearance with decision code SESE, classified as Class II. It has been determined to be substantially equivalent to other devices in this category.

  • Is the Syringe for Blood Sampling MRI compatible?

    No, the Syringe for Blood Sampling is not MRI compatible. It is designed for standard clinical laboratory use and should not be used in MRI environments.