Cefprozil 30MCG, Sensi Disc
by Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) K920473
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920473 | Date23 Mar 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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
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.