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FDA 510(k)

DBEST HCG PANEL TEST KIT

K-Number: K061257 · 2007-05-04

ApplicantAmeritek USA, Inc.
Decision Date2007-05-04
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DBEST HCG PANEL TEST KIT 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 2007-05-04 under 510(k) number K061257. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DBEST HCG PANEL TEST KIT?

DBEST HCG PANEL TEST KIT is a medical device that received FDA 510(k) clearance on 2007-05-04. The listed applicant is Ameritek USA, Inc.. The 510(k) number is K061257.

When did DBEST HCG PANEL TEST KIT receive FDA 510(k) clearance?

DBEST HCG PANEL TEST KIT received FDA 510(k) clearance on 2007-05-04, under 510(k) number K061257.

Who is the listed applicant for DBEST HCG PANEL TEST KIT?

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 HCG PANEL TEST KIT?

The FDA product code for DBEST HCG PANEL TEST KIT is JHI.

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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.

K071242DBEST ONE STEP OCCULT BLOOD TEST KITS

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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