Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2018-02-15 under approval 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. It is manufactured by Alfa Scientific Designs, Inc.. The 510(k) number is K173212.

When was Instant-view-PLUS immunochemical Fecal Occult Blood Test approved by the FDA?

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

What company makes Instant-view-PLUS immunochemical Fecal Occult Blood Test?

Instant-view-PLUS immunochemical Fecal Occult Blood Test is manufactured by Alfa Scientific Designs, Inc..

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

NCT06929481 Screening With a DNA Blood Test to Address Colorectal Cancer Inequities ACTIVE_NOT_RECRUITING NCT07216014 Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety RECRUITING NCT05655195 Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy RECRUITING

Related PubMed Literature

PMID: 39001727 Analytical Validation of the Multitarget Stool RNA Test for Colorectal Cancer Screening. The Journal of molecular diagnostics : JMD (2024)

Other Devices by Alfa Scientific Designs, Inc.

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

Related Devices (Code: KHE)

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.

↑