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FDA 510(k)

HEALTH CHECK URI-TEST PROTEIN IN URINE

K-Number: K972960 · 1998-10-07

ApplicantTcpi, Inc.
Decision Date1998-10-07
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEALTH CHECK URI-TEST PROTEIN IN URINE is the device name listed in this FDA 510(k) record. The listed applicant is Tcpi, Inc.. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K972960. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

HEALTH CHECK URI-TEST PROTEIN IN URINE is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Tcpi, Inc.. The 510(k) number is K972960.

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

HEALTH CHECK URI-TEST PROTEIN IN URINE received FDA 510(k) clearance on 1998-10-07, under 510(k) number K972960.

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

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 PROTEIN IN URINE?

The FDA product code for HEALTH CHECK URI-TEST PROTEIN IN URINE is JIR.

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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) TESTK981197ONE 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 TESTK954685URITEST - NITRITE IN URINE TEST

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Related Devices (Code: JIR)

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.

K222921Minuteful-kidney testHealthy.Io, Ltd.K210069Minuteful - kidney testHealthy.Io, Ltd.K061419TECO MICROALBUMIN 2-1 COMBO STRIPSTeco DiagnosticsK022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25Diagnostic Chemicals, Ltd. (Usa)K001810URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTINGFlexsite Diagnostics, Inc.K994035IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15Diagnostic Chemicals , 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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