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Azlocillin 75mcg Sensi-Disc

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K823800

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823800 Date7 Jan 1983ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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, 23 Sep 2026

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

AZLOCILLIN 75MCG SENSI-DISC is an antimicrobial susceptibility test disc used in microbiology to determine the effectiveness of azlocillin against bacterial infections. The device is designed for in vitro testing to identify resistant or susceptible strains of bacteria.

The disc is supplied sterile and intended for single-use in clinical laboratories. It is not reusable and must be stored according to manufacturer guidelines. The device is regulated under FDA 510(k) clearance and is classified as a Class II medical device.

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