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FDA 510(k)

ADVANTAGE HCG TEST (URINE/SERUM)

K-Number: K994227 · 2000-02-03

ApplicantAdvantage Diagnostics Corp.
Decision Date2000-02-03
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE HCG TEST (URINE/SERUM) is the device name listed in this FDA 510(k) record. The listed applicant is Advantage Diagnostics Corp.. It received FDA 510(k) clearance on 2000-02-03 under 510(k) number K994227. 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 ADVANTAGE HCG TEST (URINE/SERUM)?

ADVANTAGE HCG TEST (URINE/SERUM) is a medical device that received FDA 510(k) clearance on 2000-02-03. The listed applicant is Advantage Diagnostics Corp.. The 510(k) number is K994227.

When did ADVANTAGE HCG TEST (URINE/SERUM) receive FDA 510(k) clearance?

ADVANTAGE HCG TEST (URINE/SERUM) received FDA 510(k) clearance on 2000-02-03, under 510(k) number K994227.

Who is the listed applicant for ADVANTAGE HCG TEST (URINE/SERUM)?

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

What is the FDA product code for ADVANTAGE HCG TEST (URINE/SERUM)?

The FDA product code for ADVANTAGE HCG TEST (URINE/SERUM) is JHI.

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Other records listing Advantage Diagnostics Corp. 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.

K023712ADVANTAGE MULTIPLE DRUGS OF ABUSE TESTK013778PEACE OF MIND HOME DRUG TESTK011962ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TESTK010921ADVANTAGE MARIJUANA (THC) HOME DRUG TESTK003708ADVANTAGE THC/COCAINE TESTK001567ADVANTAGE THC TEST

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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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