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FDA 510(k)

IND ONE STEP OCCULT BLOOD (FOB) TEST

K-Number: K113506 · 2012-12-19

ApplicantInd Diagnostics, Inc.
Decision Date2012-12-19
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IND ONE STEP OCCULT BLOOD (FOB) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-12-19 under 510(k) number K113506. 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 IND ONE STEP OCCULT BLOOD (FOB) TEST?

IND ONE STEP OCCULT BLOOD (FOB) TEST is a medical device that received FDA 510(k) clearance on 2012-12-19. The listed applicant is Ind Diagnostics, Inc.. The 510(k) number is K113506.

When did IND ONE STEP OCCULT BLOOD (FOB) TEST receive FDA 510(k) clearance?

IND ONE STEP OCCULT BLOOD (FOB) TEST received FDA 510(k) clearance on 2012-12-19, under 510(k) number K113506.

Who is the listed applicant for IND ONE STEP OCCULT BLOOD (FOB) TEST?

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

What is the FDA product code for IND ONE STEP OCCULT BLOOD (FOB) TEST?

The FDA product code for IND ONE STEP OCCULT BLOOD (FOB) TEST is KHE.

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Other records listing Ind Diagnostics, 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.

K110889IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)

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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