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Propper Super Seracult(R)

by Propper Mfg. Co., Inc.

510(k) K921798

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921798 Date5 Oct 1992ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KHE
Device Class
Class II
Regulation
21 CFR Part 864.6550
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Propper Super Seracult(R) is a reagent used for occult blood testing in the field of hematology. It is intended to detect hidden blood in stool samples, aiding in the screening for gastrointestinal conditions.

The device is supplied as a reagent and is intended for single-use applications. It is not reusable and must be stored according to the manufacturer's guidelines. The device has received FDA 510(k) clearance and is classified as a Class 2 medical device.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Propper Super Seracult(R) used for?

    It is a reagent used for occult blood testing to detect hidden blood in stool samples, which aids in the screening for gastrointestinal conditions.

  • Is the Propper Super Seracult(R) intended for single use?

    Yes, the device is intended for single-use applications and must not be reused.

  • How should the Propper Super Seracult(R) be stored?

    The device must be stored according to the manufacturer's guidelines.

  • What is the regulatory status of the Propper Super Seracult(R)?

    The device has received FDA 510(k) clearance and is classified as a Class 2 medical device.