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FDA 510(k)

VISUALINE II METHAMPHETIMINE

K-Number: K972032 · 1997-08-12

ApplicantSun Biomedical Laboratories, Inc.
Decision Date1997-08-12
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VISUALINE II METHAMPHETIMINE 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 1997-08-12 under 510(k) number K972032. 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 II METHAMPHETIMINE?

VISUALINE II METHAMPHETIMINE is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Sun Biomedical Laboratories, Inc.. The 510(k) number is K972032.

When did VISUALINE II METHAMPHETIMINE receive FDA 510(k) clearance?

VISUALINE II METHAMPHETIMINE received FDA 510(k) clearance on 1997-08-12, under 510(k) number K972032.

Who is the listed applicant for VISUALINE II METHAMPHETIMINE?

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 II METHAMPHETIMINE?

The FDA product code for VISUALINE II METHAMPHETIMINE is DKZ.

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Other records listing Sun Biomedical Laboratories, 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.

K023856VISUALINE METHADONE DIPSTRIPTESTK023648VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMIK014089VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATESK020136VISUALINE BARBITURATES DIPSTRIP TESTK011499VISUALINE AMPHETAMINE DIPSTRIP ASSAYK010177VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY

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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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