Isolation of Pathogenic Neisseria

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K820847 ↗

FDA Product Code

JTY

Device Class

Class II

Regulation

21 CFR Part 866.2410

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Culture Media, Single Biochem. Test

  Class I

  FDA 510(k) K820839 Active Cleared 16 Apr 1982

• Culture Media, Selective & Differential

  Class I

  FDA 510(k) K820844 Active Cleared 16 Apr 1982

• Blue Ridge Sheep Blood

  Class I

  FDA 510(k) K820848 Active Cleared 16 Apr 1982

• Dulture Media, Selective & Non-Differ

  Class I

  FDA 510(k) K820845 Active Cleared 16 Apr 1982

• Culture Media Selective Broth

  Class I

  FDA 510(k) K820843 Active Cleared 16 Apr 1982

• Culture Media, Multiple Biochemical

  Class I

  FDA 510(k) K820841 Active Cleared 16 Apr 1982

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