Biotis (Tm) Starch Hydrolysis with Bcp

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K874174 ↗

FDA Product Code

JSF

Device Class

Class I

Regulation

21 CFR Part 866.2320

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Biotis (Tm) Haemophilus Ducreyi

  Class I

  FDA 510(k) K874176 Active Cleared 5 Feb 1988

• Biotis (Tm) Inhibitory Mold Agar (Double Pour)

  Class I

  FDA 510(k) K874172 Active Cleared 28 Oct 1987

• Biotis (Tm) Sabhi (Double Pour)

  Class I

  FDA 510(k) K874179 Active Cleared 28 Jan 1988

• Biotis (Tm) Mueller Hinton W/4% Salt, 6mcg/Ml Oxac

  Class I

  FDA 510(k) K874175 Active Cleared 4 Dec 1987

• Biotis (Tm) Bcye Selective

  Class I

  FDA 510(k) K874178 Active Cleared 4 Dec 1987

• Biotis (Tm) Bhi with Hrbc, Chlora/Gentam/Cyclohexi

  Class I

  FDA 510(k) K874173 Active Cleared 28 Oct 1987

See all devices from Otisville Biopharm, Inc. →