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Innovacon Flipcard Fecal Occult Blood Test Device

by Innovacon, Inc.

510(k) K063673

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 NumberK063673 Date5 Mar 2007ClearedStatusActive

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  • Withdrawn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, 26 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 Innovacon Flipcard Fecal Occult Blood Test Device is a reagent used for the rapid qualitative detection of human hemoglobin in fecal samples. It serves as a screening tool to identify lower gastrointestinal bleeding that may be associated with conditions such as iron deficiency anemia, peptic ulcer, ulcerative colitis, polyps, and colorectal cancer.

This device has received FDA 510(k) clearance and is classified under regulation number 864.6550. It is intended for use in clinical settings for the analysis of fecal specimens.

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Questions

AI-generated answers, 26 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 primary purpose of the Innovacon Flipcard?

    This device is a rapid qualitative reagent used to detect human hemoglobin in fecal samples. It acts as a screening tool to help clinicians identify lower gastrointestinal bleeding, which may be associated with conditions such as colorectal cancer, polyps, peptic ulcers, or iron deficiency anemia.

  • In what environment is this device intended to be used?

    The Innovacon Flipcard is intended for use in clinical settings. It is designed for the analysis of fecal specimens by healthcare professionals to assist in the diagnostic screening process.

  • Has this device undergone a formal regulatory review?

    Yes, the Innovacon Flipcard Fecal Occult Blood Test Device has received FDA 510(k) clearance. It is classified under regulation number 864.6550 and is categorized under the hematology advisory committee.