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FDA 510(k)

INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST

K-Number: K070660 · 2007-06-21

ApplicantAlfa Scientific Designs, Inc.
Decision Date2007-06-21
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID 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 2007-06-21 under 510(k) number K070660. 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 FECAL OCCULT BLOOD (FOB) RAPID TEST?

INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST is a medical device that received FDA 510(k) clearance on 2007-06-21. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K070660.

When did INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST receive FDA 510(k) clearance?

INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST received FDA 510(k) clearance on 2007-06-21, under 510(k) number K070660.

Who is the listed applicant for INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID 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 FECAL OCCULT BLOOD (FOB) RAPID TEST?

The FDA product code for INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST is KHE.

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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.

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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.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC

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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