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FDA 510(k)

DBEST ONE STEP OCCULT BLOOD TEST KITS

K-Number: K071242 · 2008-03-06

ApplicantAmeritek USA, Inc.
Decision Date2008-03-06
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DBEST ONE STEP OCCULT BLOOD TEST KITS is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek USA, Inc.. It received FDA 510(k) clearance on 2008-03-06 under 510(k) number K071242. 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 DBEST ONE STEP OCCULT BLOOD TEST KITS?

DBEST ONE STEP OCCULT BLOOD TEST KITS is a medical device that received FDA 510(k) clearance on 2008-03-06. The listed applicant is Ameritek USA, Inc.. The 510(k) number is K071242.

When did DBEST ONE STEP OCCULT BLOOD TEST KITS receive FDA 510(k) clearance?

DBEST ONE STEP OCCULT BLOOD TEST KITS received FDA 510(k) clearance on 2008-03-06, under 510(k) number K071242.

Who is the listed applicant for DBEST ONE STEP OCCULT BLOOD TEST KITS?

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

What is the FDA product code for DBEST ONE STEP OCCULT BLOOD TEST KITS?

The FDA product code for DBEST ONE STEP OCCULT BLOOD TEST KITS is KHE.

Related Clinical Trials

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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Other records listing Ameritek USA, 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.

K061257DBEST HCG PANEL TEST KIT

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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