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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 a medical device manufactured by Immunostics Inc.,. It received FDA 510(k) clearance on 2017-01-17 under approval 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. It is manufactured by Immunostics Inc.,. The 510(k) number is K163554.

When was hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test approved by the FDA?

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

What company makes hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test?

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test is manufactured by Immunostics Inc.,.

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.

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Other Devices by Immunostics Inc.,

K163465hemochroma PLUS System K163225AFIAS iFOB with AFIAS-50 K171484hema-screen SPECIFIC Gold K182298hemochroma PLUS System K221817ALFIS Vitamin D, ALFIS-3 Analyzer

Related Devices (Code: KHE)

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

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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