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FDA 510(k)

VISUALINE II BENZODIAZEPINES

K-Number: K953105 · 1995-10-05

ApplicantSun Biomedical Laboratories, Inc.
Decision Date1995-10-05
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VISUALINE II BENZODIAZEPINES 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 1995-10-05 under 510(k) number K953105. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUALINE II BENZODIAZEPINES?

VISUALINE II BENZODIAZEPINES is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Sun Biomedical Laboratories, Inc.. The 510(k) number is K953105.

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

VISUALINE II BENZODIAZEPINES received FDA 510(k) clearance on 1995-10-05, under 510(k) number K953105.

Who is the listed applicant for VISUALINE II BENZODIAZEPINES?

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 BENZODIAZEPINES?

The FDA product code for VISUALINE II BENZODIAZEPINES is JXM.

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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: JXM)

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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.

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