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FDA 510(k)

HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

K-Number: K954968 · 1996-07-26

ApplicantTcpi, Inc.
Decision Date1996-07-26
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEALTH CHECK URI-TEST GLUCOSE 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 1996-07-26 under 510(k) number K954968. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST?

HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST is a medical device that received FDA 510(k) clearance on 1996-07-26. The listed applicant is Tcpi, Inc.. The 510(k) number is K954968.

When did HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST receive FDA 510(k) clearance?

HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST received FDA 510(k) clearance on 1996-07-26, under 510(k) number K954968.

Who is the listed applicant for HEALTH CHECK URI-TEST GLUCOSE 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 HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST?

The FDA product code for HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST is JIL.

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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)K954685URITEST - NITRITE IN URINE TEST

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Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

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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