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FDA 510(k)

FLEXSURE OBT

K-Number: K961062 · 1996-11-06

ApplicantSmithkline Diagnostics, Inc.
Decision Date1996-11-06
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLEXSURE OBT is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-11-06 under 510(k) number K961062. 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 FLEXSURE OBT?

FLEXSURE OBT is a medical device that received FDA 510(k) clearance on 1996-11-06. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K961062.

When did FLEXSURE OBT receive FDA 510(k) clearance?

FLEXSURE OBT received FDA 510(k) clearance on 1996-11-06, under 510(k) number K961062.

Who is the listed applicant for FLEXSURE OBT?

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

What is the FDA product code for FLEXSURE OBT?

The FDA product code for FLEXSURE OBT is KHE.

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Other records listing Smithkline 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.

K960183FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)K934863FLEXSURE HPK880499HEMOCCULT SENSITIVE TESTK875131(SKD) CHOLESTEROL TEST KITK862849HEMOCCULT WIPE TESTK854723SKD ELECTROCHEMICAL SYSTEM (ECS)

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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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