Sulfacytine 0.25 Mg

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

510(k) Number

K760701 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Sulfacytine 0.25 Mg disc used for?

  The Sulfacytine 0.25 Mg disc is an antimicrobial susceptibility test disc used in microbiology laboratories to determine the effectiveness of sulfacytine against bacterial isolates, helping clinicians select appropriate antimicrobial therapy.

• How is the Sulfacytine 0.25 Mg disc supplied?

  The disc is supplied as a single-use device, classified as a Class 2 medical device with product code JTN, and is intended for in vitro diagnostic use in microbiology settings following established laboratory protocols.

• What is the regulatory status of the Sulfacytine 0.25 Mg disc?

  The device was cleared through the Traditional 510(k) pathway on November 16, 1976, after being received by the FDA on September 22, 1976, and is regulated under 866.1620 as a substantially equivalent device.

• How should the Sulfacytine 0.25 Mg disc be stored?

  The device should be stored according to the manufacturer's instructions to maintain its integrity and effectiveness for antimicrobial susceptibility testing, though specific storage conditions are not detailed in the provided information.