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FDA 510(k)

URITEST - NITRITE IN URINE TEST

K-Number: K954685 · 1996-07-22

ApplicantTcpi, Inc.
Decision Date1996-07-22
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URITEST - NITRITE IN URINE 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 1996-07-22 under 510(k) number K954685. The device is classified under product code JMT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITEST - NITRITE IN URINE TEST?

URITEST - NITRITE IN URINE TEST is a medical device that received FDA 510(k) clearance on 1996-07-22. The listed applicant is Tcpi, Inc.. The 510(k) number is K954685.

When did URITEST - NITRITE IN URINE TEST receive FDA 510(k) clearance?

URITEST - NITRITE IN URINE TEST received FDA 510(k) clearance on 1996-07-22, under 510(k) number K954685.

Who is the listed applicant for URITEST - NITRITE IN URINE 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 URITEST - NITRITE IN URINE TEST?

The FDA product code for URITEST - NITRITE IN URINE TEST is JMT.

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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 TESTK980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTK951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

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Related Devices (Code: JMT)

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.

K251800Healgen® URS Test StripsHealgen Scientific,, LLCK252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.K170118Scanostics UTI Check Application Test SystemTeco DiagnosticsK100024TECO DIAGNOSTICS UTI DETECTION STRIPSTeco DiagnosticsK993850URINALYSIS REAGENT STRIPS (10 PARAMETERS)International Newtech Development, 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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