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FDA 510(k)

LIVESURE AMPHETAMINE SCREEN TEST

K-Number: K011609 · 2001-06-08

ApplicantPan Probe Biotech, Inc.
Decision Date2001-06-08
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LIVESURE AMPHETAMINE SCREEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pan Probe Biotech, Inc.. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K011609. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIVESURE AMPHETAMINE SCREEN TEST?

LIVESURE AMPHETAMINE SCREEN TEST is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Pan Probe Biotech, Inc.. The 510(k) number is K011609.

When did LIVESURE AMPHETAMINE SCREEN TEST receive FDA 510(k) clearance?

LIVESURE AMPHETAMINE SCREEN TEST received FDA 510(k) clearance on 2001-06-08, under 510(k) number K011609.

Who is the listed applicant for LIVESURE AMPHETAMINE SCREEN TEST?

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

What is the FDA product code for LIVESURE AMPHETAMINE SCREEN TEST?

The FDA product code for LIVESURE AMPHETAMINE SCREEN TEST is DKZ.

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Other records listing Pan Probe Biotech, 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.

K020968LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARDK013796LIVESURE METHADONE SCREEN TESTSK012133LIVESURE BARBITURATES SCREEN TESTK012131LIVESURE BENZODIAZEPINES SCREEN TESTSK012107LIVESURE PHENECYCLINE (PCP) SCREEN TESTSK011610LIVESURE METHAMPHETAMINE SCREEN TESTS

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Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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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