Gc Base W/ 1% Gchi

• • Ongoing Z-2623-2026 FDA Class II ·initiated 3 Jun 2026

  Reduced or no recovery of some strains of Neisseria gonorrhoeae.

510(k) Number

K954986 ↗

FDA Product Code

JTY

Device Class

Class II

Regulation

21 CFR Part 866.2410

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Rpr Card Test Kit

  Class II

  FDA 510(k) K955136 Active Cleared 29 Jul 1996

• 10B Arginine Broth

  Class I

  FDA 510(k) K961046 Active Cleared 18 Sep 1996

• Remel Meropenem 10UG Susceptibility Disk

  Class II

  FDA 510(k) K964421 Active Cleared 6 Dec 1996

• Rpr Liquid Controls

  Class II

  FDA 510(k) K955143 Active Cleared 30 Jul 1996

• Mueller Hinton Agar with 2% Naci

  Class II

  FDA 510(k) K960313 Active Cleared 25 Mar 1996

• Remel Bile Esculin Azide Agar W/6 Mcg/Ml Vancomycin

  Class II

  FDA 510(k) K972359 Active Cleared 28 Aug 1997

See all devices from Remel, L.P. →