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IFA Sensibac Cefaclor

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

510(k) K892721

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 NumberK892721 Date30 Nov 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  • Withdrawn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
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

IFA Sensibac Cefaclor is a susceptibility test disc used for antimicrobial testing in microbiology laboratories. The device is designed to determine the susceptibility of microorganisms to cefaclor, a cephalosporin antibiotic, through standardized testing methods.

The device is supplied as a single-use product and is classified under product code JTN with FDA 510(k) clearance K892721. It is manufactured by Investigacion Farmaceutica S.A. DE C.V. in Mexico and is regulated under 866.1620. The device is available in various sizes and is intended for laboratory use only.

Other devices from Investigacion Farmaceutica S.A. DE C.V.

See all devices from Investigacion Farmaceutica S.A. DE C.V. →

Questions

AI-generated answers, 28 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 IFA Sensibac Cefaclor used for?

    The IFA Sensibac Cefaclor is a susceptibility test disc designed to determine the susceptibility of microorganisms to cefaclor, a cephalosporin antibiotic, through standardized testing methods in microbiology laboratories.

  • How is the IFA Sensibac Cefaclor supplied and is it reusable?

    The device is supplied as a single-use product and is not intended for reuse. It is classified under product code JTN and is available in various sizes for laboratory use only.

  • What is the regulatory status of the IFA Sensibac Cefaclor?

    The IFA Sensibac Cefaclor has FDA 510(k) clearance K892721 and is classified under product code JTN with regulation number 866.1620. It is manufactured by Investigacion Farmaceutica S.A. DE C.V. in Mexico.

  • What are the storage requirements for the IFA Sensibac Cefaclor?

    The device should be stored according to the manufacturer's instructions to maintain its integrity for accurate testing results. Specific storage conditions are not detailed in the provided information.