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FDA 510(k)

HEMA SCREEN SPECIFIC IFOBT

K-Number: K060463 · 2006-06-06

ApplicantImmunostics Inc.,
Decision Date2006-06-06
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMA SCREEN SPECIFIC IFOBT is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2006-06-06 under 510(k) number K060463. 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 IFOBT?

HEMA SCREEN SPECIFIC IFOBT is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Immunostics Inc.,. The 510(k) number is K060463.

When did HEMA SCREEN SPECIFIC IFOBT receive FDA 510(k) clearance?

HEMA SCREEN SPECIFIC IFOBT received FDA 510(k) clearance on 2006-06-06, under 510(k) number K060463.

Who is the listed applicant for HEMA SCREEN SPECIFIC IFOBT?

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 IFOBT?

The FDA product code for HEMA SCREEN SPECIFIC IFOBT is KHE.

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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-50K171484hema-screen SPECIFIC GoldK163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

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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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