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IFA Sensibac Polymyxin B Susceptibility Test Discs

by Investigacion Farmaceutica S.A. DE C.V.

510(k) K892723

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 NumberK892723 Date3 Aug 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  • Withdrawn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)

Full name
Ifa Sensibac Polymyxin B
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, 19 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 IFA Sensibac Polymyxin B is a susceptibility test disc classified under Susceptibility Test Discs, Antimicrobial. It is designed for use in microbiological testing to determine the sensitivity of bacterial isolates to polymyxin B, aiding in the selection of appropriate antimicrobial therapy.

This device is supplied as single-use antimicrobial susceptibility discs and is regulated under FDA 510(k) clearance (K892723) with a classification of Class II. It falls under the regulatory scope of 21 CFR 866.1620 and is intended for use in microbiology laboratories. The discs are not sterile and must be handled in accordance with standard microbiological practices.

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