Propper Seracult

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K834297 ↗

FDA Product Code

KHE

Device Class

Class II

Regulation

21 CFR Part 864.6550

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Ok Flash Sterilization Indicator

  Class II

  FDA 510(k) K834353 Active Cleared 19 Mar 1984

• Bi-O.K.(Tm)-Biological/Chemical Indicator

  Class II

  FDA 510(k) K891784 Active Cleared 9 Feb 1990

• Once-A-Day Vertos Test Pack

  Class II

  FDA 510(k) K082620 Active Cleared 8 Jul 2009

• Bio-Challenge Test Pak

  Class II

  FDA 510(k) K851804 Active Cleared 16 Jul 1985

• Propper Super Seracult(R)

  Class II

  FDA 510(k) K921798 Active Cleared 5 Oct 1992

• Bi-O.K. EO Gas Biological Test-Pak (269305, 269310, 269320)

  Class II

  FDA 510(k) K972747 Active Cleared 9 Jan 1998

See all devices from Propper Mfg. Co., Inc. →

• What is Propper Seracult used for?

  Propper Seracult is a qualitative aid in the diagnosis of colorectal cancer. It functions as a fecal occult blood test that can detect 90% of colorectal cancers that bleed, making it useful for routine examinations in medical settings or at home.

• How is Propper Seracult supplied?

  Propper Seracult is supplied as either single slides or triple slides for serial testing. This allows for flexibility in testing protocols depending on clinical requirements or patient needs.

• Is Propper Seracult a single-use device?

  The device is a reagent for occult blood testing and is classified as a Class II medical device. While the description doesn't explicitly state single-use or reuse, it's typically designed for one-time testing per slide.

• What regulatory authorization does Propper Seracult have?

  Propper Seracult is authorized under FDA 510K with product code KHE. It is manufactured by Propper Mfg. Co., Inc. and is classified as a Class II medical device for reagent occult blood testing.