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FDA 510(k)

Instant-view-PLUS immunochemical Fecal Occult Blood Test

K-Number: K173212 · 2018-02-15

ApplicantAlfa Scientific Designs, Inc.
Decision Date2018-02-15
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Instant-view-PLUS immunochemical Fecal Occult Blood Test is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2018-02-15 under 510(k) number K173212. 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 Instant-view-PLUS immunochemical Fecal Occult Blood Test?

Instant-view-PLUS immunochemical Fecal Occult Blood Test is a medical device that received FDA 510(k) clearance on 2018-02-15. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K173212.

When did Instant-view-PLUS immunochemical Fecal Occult Blood Test receive FDA 510(k) clearance?

Instant-view-PLUS immunochemical Fecal Occult Blood Test received FDA 510(k) clearance on 2018-02-15, under 510(k) number K173212.

Who is the listed applicant for Instant-view-PLUS immunochemical Fecal Occult Blood Test?

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

What is the FDA product code for Instant-view-PLUS immunochemical Fecal Occult Blood Test?

The FDA product code for Instant-view-PLUS immunochemical Fecal Occult Blood Test is KHE.

Related Clinical Trials

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NCT06929481Screening With a DNA Blood Test to Address Colorectal Cancer InequitiesACTIVE_NOT_RECRUITING

Other records listing Alfa Scientific Designs, 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.

K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

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.

K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics 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

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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