Cefmatzole 30 Mcg Sensi Disc

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K895679 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the Cefmatzole 30 Mcg Sensi Disc used for?

  The Cefmatzole 30 Mcg Sensi Disc is an antimicrobial susceptibility test disc used in microbiology laboratories to determine the effectiveness of cefmetazole against microorganisms. It contains 30 micrograms of cefmetazole antibiotic.

• How is the Cefmatzole 30 Mcg Sensi Disc supplied and used?

  The device is supplied as a single-use disc that is placed on an agar plate inoculated with bacteria to assess susceptibility. It is not intended for MRI use and should be stored according to manufacturer instructions.

• What is the regulatory status of the Cefmatzole 30 Mcg Sensi Disc?

  The Cefmatzole 30 Mcg Sensi Disc is authorized under FDA 510(k) clearance K895679 and is classified under product code JTN. It is manufactured by Becton Dickinson Vacutainer Systems Preanalytic.

• Is the Cefmatzole 30 Mcg Sensi Disc reusable or single-use?

  The Cefmatzole 30 Mcg Sensi Disc is designed as a single-use device and should not be reused. Each disc contains a specific amount of cefmetazole antibiotic for one test only.