FDA 510(k)

VISUALINE AMPHETAMINE DIPSTRIP ASSAY

K-Number: K011499 · 2001-07-17

ApplicantSun Biomedical Laboratories, Inc.

Decision Date2001-07-17

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

VISUALINE AMPHETAMINE DIPSTRIP ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Sun Biomedical Laboratories, Inc.. It received FDA 510(k) clearance on 2001-07-17 under 510(k) number K011499. 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 VISUALINE AMPHETAMINE DIPSTRIP ASSAY?

VISUALINE AMPHETAMINE DIPSTRIP ASSAY is a medical device that received FDA 510(k) clearance on 2001-07-17. The listed applicant is Sun Biomedical Laboratories, Inc.. The 510(k) number is K011499.

When did VISUALINE AMPHETAMINE DIPSTRIP ASSAY receive FDA 510(k) clearance?

VISUALINE AMPHETAMINE DIPSTRIP ASSAY received FDA 510(k) clearance on 2001-07-17, under 510(k) number K011499.

Who is the listed applicant for VISUALINE AMPHETAMINE DIPSTRIP ASSAY?

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

What is the FDA product code for VISUALINE AMPHETAMINE DIPSTRIP ASSAY?

The FDA product code for VISUALINE AMPHETAMINE DIPSTRIP ASSAY is DKZ.

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Other records listing Sun Biomedical Laboratories, Inc. as applicant

K023856VISUALINE METHADONE DIPSTRIPTEST K023648VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI K014089VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES K020136VISUALINE BARBITURATES DIPSTRIP TEST K010177VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY K993485VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE

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Related Devices (Code: DKZ)

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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.