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FDA 510(k)

ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST

K-Number: K980776 · 1998-04-29

ApplicantTcpi, Inc.
Decision Date1998-04-29
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE 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 1998-04-29 under 510(k) number K980776. 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 ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST?

ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Tcpi, Inc.. The 510(k) number is K980776.

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

ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST received FDA 510(k) clearance on 1998-04-29, under 510(k) number K980776.

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

The FDA product code for ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST is JXM.

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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 URINEK981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TESTK951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TESTK954685URITEST - NITRITE IN URINE TEST

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Related Devices (Code: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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