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FDA 510(k)

CHEK-STIX U.T.I. SELF-TEST

K-Number: K960888 · 1996-07-05

ApplicantBayer Corp.
Decision Date1996-07-05
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEK-STIX U.T.I. SELF-TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1996-07-05 under 510(k) number K960888. 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 CHEK-STIX U.T.I. SELF-TEST?

CHEK-STIX U.T.I. SELF-TEST is a medical device that received FDA 510(k) clearance on 1996-07-05. The listed applicant is Bayer Corp.. The 510(k) number is K960888.

When did CHEK-STIX U.T.I. SELF-TEST receive FDA 510(k) clearance?

CHEK-STIX U.T.I. SELF-TEST received FDA 510(k) clearance on 1996-07-05, under 510(k) number K960888.

Who is the listed applicant for CHEK-STIX U.T.I. SELF-TEST?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEK-STIX U.T.I. SELF-TEST?

The FDA product code for CHEK-STIX U.T.I. SELF-TEST is JMT.

Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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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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