Culture and Sensitivity Kit

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K791413 ↗

FDA Product Code

JTZ

Device Class

Class II

Regulation

21 CFR Part 866.1700

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Strep Blood Agar-5% Sheep Blood

  Class I

  FDA 510(k) K790469 Active Cleared 4 Apr 1979

• Dtm (Dermatophyte Test Medium) Agar

  Class I

  FDA 510(k) K791414 Active Cleared 17 Oct 1979

• Modified Thayer Martin Agar

  Class II

  FDA 510(k) K790368 Active Cleared 21 Mar 1979

• Tryptic Soy Agar W/5% & 10% Sheep Blood

  Class I

  FDA 510(k) K811475 Active Cleared 18 Jun 1981

• Emb/Mueller-Hinton Agar

  Class II

  FDA 510(k) K790369 Active Cleared 23 Apr 1979

• Thayer Martin Agar

  Class II

  FDA 510(k) K811476 Active Cleared 18 Jun 1981

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