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FDA 510(k)

BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST

K-Number: K023944 · 2003-02-11

ApplicantBayer Corp.
Decision Date2003-02-11
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BAYER DIAGNOSTICS CLINITEST PREGNANCY 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 2003-02-11 under 510(k) number K023944. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST?

BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is Bayer Corp.. The 510(k) number is K023944.

When did BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST receive FDA 510(k) clearance?

BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST received FDA 510(k) clearance on 2003-02-11, under 510(k) number K023944.

Who is the listed applicant for BAYER DIAGNOSTICS CLINITEST PREGNANCY 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 BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST?

The FDA product code for BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST is JHI.

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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 METERK024017BAYER 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 SYSTEMK020828CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM

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Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. 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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