Streptomycin Disk (300MCG)

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

510(k) Number

K961819 ↗

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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  FDA 510(k) K955136 Active Cleared 29 Jul 1996

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  FDA 510(k) K961046 Active Cleared 18 Sep 1996

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See all devices from Remel, L.P. →

• What is the Streptomycin Disk used for?

  The Streptomycin Disk is used to measure the in vitro susceptibility of bacterial pathogens to antimicrobial agents by a disc-agar diffusion technique or a disc-broth elution technique.

• How is the Streptomycin Disk supplied?

  The Streptomycin Disk is supplied with a specification of 300mcg, and it consists of antimicrobic-impregnated paper discs.

• Is the Streptomycin Disk a single-use or reusable device?

  The device is a single product, but its single-use or reuse status is not explicitly stated.

• What is the regulatory classification of the Streptomycin Disk?

  The device is classified as a class 2 device, with a traditional clearance type, and has an FDA 510(k) clearance with a regulation number of 866.1620.