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FDA 510(k)

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

K-Number: K163554 · 2017-01-17

ApplicantImmunostics Inc.,
Decision Date2017-01-17
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2017-01-17 under 510(k) number K163554. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test?

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test is a medical device that received FDA 510(k) clearance on 2017-01-17. The listed applicant is Immunostics Inc.,. The 510(k) number is K163554.

When did hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test receive FDA 510(k) clearance?

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test received FDA 510(k) clearance on 2017-01-17, under 510(k) number K163554.

Who is the listed applicant for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test?

The FDA 510(k) record lists Immunostics Inc., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test?

The FDA product code for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test is KHE.

Other records listing Immunostics Inc., as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221817ALFIS Vitamin D, ALFIS-3 AnalyzerK182298hemochroma PLUS SystemK163465hemochroma PLUS SystemK163225AFIAS iFOB with AFIAS-50K171484hema-screen SPECIFIC Gold

Related Devices (Code: KHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics Inc.,K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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