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FDA 510(k)

hema-screen SPECIFIC Gold

K-Number: K171484 · 2017-06-14

ApplicantImmunostics Inc.,
Decision Date2017-06-14
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

hema-screen SPECIFIC Gold is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K171484. 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 SPECIFIC Gold?

hema-screen SPECIFIC Gold is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Immunostics Inc.,. The 510(k) number is K171484.

When did hema-screen SPECIFIC Gold receive FDA 510(k) clearance?

hema-screen SPECIFIC Gold received FDA 510(k) clearance on 2017-06-14, under 510(k) number K171484.

Who is the listed applicant for hema-screen SPECIFIC Gold?

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 SPECIFIC Gold?

The FDA product code for hema-screen SPECIFIC Gold 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-50K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

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.K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,

Official Source

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

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