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FDA 510(k)

VICTORCH HCG TEST STRIP

K-Number: K013702 · 2001-12-27

ApplicantVictorch Meditek, Inc.
Decision Date2001-12-27
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VICTORCH HCG TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Victorch Meditek, Inc.. It received FDA 510(k) clearance on 2001-12-27 under 510(k) number K013702. 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 VICTORCH HCG TEST STRIP?

VICTORCH HCG TEST STRIP is a medical device that received FDA 510(k) clearance on 2001-12-27. The listed applicant is Victorch Meditek, Inc.. The 510(k) number is K013702.

When did VICTORCH HCG TEST STRIP receive FDA 510(k) clearance?

VICTORCH HCG TEST STRIP received FDA 510(k) clearance on 2001-12-27, under 510(k) number K013702.

Who is the listed applicant for VICTORCH HCG TEST STRIP?

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

What is the FDA product code for VICTORCH HCG TEST STRIP?

The FDA product code for VICTORCH HCG TEST STRIP is JHI.

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 Victorch Meditek, 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.

K013678VICTORCH MEDITEK'S HCG TEST CARD

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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