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Cefprozil 30MCG, Sensi Disc

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K920473

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 NumberK920473 Date23 Mar 1992ClearedStatusActive

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  • Withdrawn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, 27 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 Cefprozil 30mcg, Sensi Disc is an antimicrobial susceptibility test disc used in microbiology laboratories to determine the effectiveness of cefprozil against bacteria. This device is part of the BD BBL™ Sensi-Disc™ portfolio, which provides disk diffusion solutions for laboratory testing. The disc contains 30 micrograms of cefprozil and is designed to be used in standard susceptibility testing procedures.

The Cefprozil 30mcg, Sensi Disc is supplied as a single-use product and requires appropriate storage conditions to maintain its integrity. It is classified as a Class II medical device under product code JTN with special controls. The device has received FDA 510(k) clearance (K920473) and is manufactured by BD Becton Dickinson Vacutainer Systems Preanalytic in Cockeysville, US.

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Questions

AI-generated answers, 27 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 Cefprozil 30mcg Sensi Disc used for?

    The Cefprozil 30mcg Sensi Disc is an antimicrobial susceptibility test disc used in microbiology laboratories to determine the effectiveness of cefprozil against bacteria. It is part of the BD BBL™ Sensi-Disc™ portfolio for disk diffusion testing.

  • How is the Cefprozil 30mcg Sensi Disc supplied and stored?

    The Cefprozil 30mcg Sensi Disc is supplied as a single-use product that requires appropriate storage conditions to maintain its integrity. It is classified as a Class II medical device under product code JTN with special controls.

  • What is the regulatory status of the Cefprozil 30mcg Sensi Disc?

    The Cefprozil 30mcg Sensi Disc has received FDA 510(k) clearance (K920473) and is manufactured by BD Becton Dickinson Vacutainer Systems Preanalytic in Cockeysville, US. It is classified as a Class II medical device under product code JTN with special controls.

  • What is the composition of the Cefprozil 30mcg Sensi Disc?

    The disc contains 30 micrograms of cefprozil and is designed to be used in standard susceptibility testing procedures. It is part of the BD BBL™ Sensi-Disc™ portfolio, which provides disk diffusion solutions for laboratory testing.