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FDA 510(k)

ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST

K-Number: K973047 · 1997-10-02

ApplicantDrial Consultants, Inc.
Decision Date1997-10-02
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Drial Consultants, Inc.. It received FDA 510(k) clearance on 1997-10-02 under 510(k) number K973047. 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 ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST?

ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST is a medical device that received FDA 510(k) clearance on 1997-10-02. The listed applicant is Drial Consultants, Inc.. The 510(k) number is K973047.

When did ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST receive FDA 510(k) clearance?

ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST received FDA 510(k) clearance on 1997-10-02, under 510(k) number K973047.

Who is the listed applicant for ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST?

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

What is the FDA product code for ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST?

The FDA product code for ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST is DIS.

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Other records listing Drial Consultants, 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.

K973269QUIKSTRIP ONE STEP BENZODIAZEPINE TESTK973326QUIKPAC II ONE STEP BENZODIAZEPINE TESTK972059QUIKPAC II ONE STEP COCAINE TESTK972571QUIKSTRIP ONE STEP OPIATES TESTK972405QUIKPAC II ONE STEP OPIATE TESTK971926QUIKSTRIP ONE STEP COCAINE TEST

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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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