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FDA 510(k)

VISUALINE II MORPHINE/OPIATES/HEROIN

K-Number: K943248 · 1995-01-30

ApplicantSun Biomedical Laboratories, Inc.
Decision Date1995-01-30
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VISUALINE II MORPHINE/OPIATES/HEROIN 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 1995-01-30 under 510(k) number K943248. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUALINE II MORPHINE/OPIATES/HEROIN?

VISUALINE II MORPHINE/OPIATES/HEROIN is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Sun Biomedical Laboratories, Inc.. The 510(k) number is K943248.

When did VISUALINE II MORPHINE/OPIATES/HEROIN receive FDA 510(k) clearance?

VISUALINE II MORPHINE/OPIATES/HEROIN received FDA 510(k) clearance on 1995-01-30, under 510(k) number K943248.

Who is the listed applicant for VISUALINE II MORPHINE/OPIATES/HEROIN?

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 MORPHINE/OPIATES/HEROIN?

The FDA product code for VISUALINE II MORPHINE/OPIATES/HEROIN is DJG.

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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: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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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