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Drug Standard Set

by Gelman Sciences, Inc.

510(k) K884177

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 NumberK884177 Date17 Feb 1989ClearedStatusActive

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  • Withdrawn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
DKB
Device Class
Class II
Regulation
21 CFR Part 862.3200
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

This device is a calibrator for drug mixtures, classified under medical specialty Clinical Toxicology. It is a substantially equivalent device cleared via traditional 510(k) pathway.

It is supplied by Gelman Sciences, Inc. and has FDA 510(k) clearance K884177, granted on February 17, 1989. The device is regulated under regulation number 862.3200 and is intended for use in clinical toxicology settings.

Other devices from Gelman Sciences, Inc.

See all devices from Gelman Sciences, Inc. →

Questions

AI-generated answers, 6 Oct 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 DRUG STANDARD SET used for?

    The DRUG STANDARD SET is a calibrator for drug mixtures intended for use in clinical toxicology settings to ensure accurate measurement and calibration of drug concentrations in samples.

  • How is the DRUG STANDARD SET supplied and by whom?

    The DRUG STANDARD SET is supplied by Gelman Sciences, Inc., located at 600 S Wagner Rd., Ann Arbor, MI 48103, as a calibrated reference set for drug mixture analysis.

  • Is the DRUG STANDARD SET sterile or single-use?

    The device data does not specify sterility or single-use status; as a calibrator for drug mixtures, it is likely intended for repeated use in laboratory settings under controlled conditions.

  • What regulatory pathway cleared the DRUG STANDARD SET?

    The DRUG STANDARD SET received FDA 510(k) clearance K884177 through the traditional pathway on February 17, 1989, as a substantially equivalent device under regulation 862.3200.

  • What is the device classification and product code for the DRUG STANDARD SET?

    The DRUG STANDARD SET is classified as a Class II medical device with product code DKB, regulated under 862.3200 for calibrators, drug mixture, in the Clinical Toxicology specialty.