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FDA 510(k)

ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST

K-Number: K981197 · 1998-06-16

ApplicantTcpi, Inc.
Decision Date1998-06-16
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tcpi, Inc.. It received FDA 510(k) clearance on 1998-06-16 under 510(k) number K981197. 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 ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST?

ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST is a medical device that received FDA 510(k) clearance on 1998-06-16. The listed applicant is Tcpi, Inc.. The 510(k) number is K981197.

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

ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST received FDA 510(k) clearance on 1998-06-16, under 510(k) number K981197.

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

The FDA 510(k) record lists Tcpi, 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 AMPHETAMINE TEST?

The FDA product code for ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST is DKZ.

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Other records listing Tcpi, 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.

K981363ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TESTK972960HEALTH CHECK URI-TEST PROTEIN IN URINEK980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTK951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TESTK954685URITEST - NITRITE IN URINE TEST

View all 14 devices →

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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