Biotis Potato Dextrose Agar

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K860398 ↗

FDA Product Code

JSJ

Device Class

Class I

Regulation

21 CFR Part 866.2360

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Biotis Tsa with 5% Rabbit Blood

  Class I

  FDA 510(k) K860403 Active Cleared 24 Feb 1986

• Biotis Bhi Agar

  Class I

  FDA 510(k) K860411 Active Cleared 24 Feb 1986

• Biotis Martin Lewis Agar

  Class II

  FDA 510(k) K843817 Active Cleared 10 Oct 1984

• Esculin Agar Plate

  Class I

  FDA 510(k) K840073 Active Cleared 3 Feb 1984

• Biotis Ornithine Indole Motility Media

  Class I

  FDA 510(k) K860414 Active Cleared 24 Feb 1986

• Biotis Sabhi with Chloramphenical and Gentamycin

  Class I

  FDA 510(k) K860390 Active Cleared 24 Feb 1986

See all devices from Otisville Biotech, Inc. →