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Aztreonam 30 Mcg Sensitivity Disks

by Difco Laboratories, Inc.

510(k) K870347

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 NumberK870347 Date5 Mar 1987ClearedStatusActive

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  • Withdrawn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
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

Aztreonam 30 Mcg Sensitivity Disks are susceptibility test discs, antimicrobial, used for determining the sensitivity of microorganisms to aztreonam. The device contains a 30 microgram concentration of aztreonam on a paper disk for use in antimicrobial susceptibility testing.

These disks are supplied as a diagnostic microbiology device and are intended for use in clinical laboratory settings. The device received FDA 510(k) clearance (K870347) on March 5, 1987, and is classified under regulation number 866.1620 with product code JTN. It is marketed under the Sensi-Disc™ brand by Difco Laboratories, Inc.

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