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FDA 510(k)

VISUALINE BARBITURATES DIPSTRIP TEST

K-Number: K020136 · 2002-03-20

ApplicantSun Biomedical Laboratories, Inc.
Decision Date2002-03-20
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VISUALINE BARBITURATES DIPSTRIP TEST 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 2002-03-20 under 510(k) number K020136. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUALINE BARBITURATES DIPSTRIP TEST?

VISUALINE BARBITURATES DIPSTRIP TEST is a medical device that received FDA 510(k) clearance on 2002-03-20. The listed applicant is Sun Biomedical Laboratories, Inc.. The 510(k) number is K020136.

When did VISUALINE BARBITURATES DIPSTRIP TEST receive FDA 510(k) clearance?

VISUALINE BARBITURATES DIPSTRIP TEST received FDA 510(k) clearance on 2002-03-20, under 510(k) number K020136.

Who is the listed applicant for VISUALINE BARBITURATES DIPSTRIP TEST?

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 BARBITURATES DIPSTRIP TEST?

The FDA product code for VISUALINE BARBITURATES DIPSTRIP TEST is DIS.

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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) BARITURATESK011499VISUALINE AMPHETAMINE DIPSTRIP ASSAYK010177VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAYK993485VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE

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Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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