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FDA 510(k)

LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD

K-Number: K020968 · 2002-07-15

ApplicantPan Probe Biotech, Inc.
Decision Date2002-07-15
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD is the device name listed in this FDA 510(k) record. The listed applicant is Pan Probe Biotech, Inc.. It received FDA 510(k) clearance on 2002-07-15 under 510(k) number K020968. 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 LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD?

LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD is a medical device that received FDA 510(k) clearance on 2002-07-15. The listed applicant is Pan Probe Biotech, Inc.. The 510(k) number is K020968.

When did LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD receive FDA 510(k) clearance?

LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD received FDA 510(k) clearance on 2002-07-15, under 510(k) number K020968.

Who is the listed applicant for LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD?

The FDA 510(k) record lists Pan Probe Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD?

The FDA product code for LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD is JHI.

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Other records listing Pan Probe Biotech, 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.

K013796LIVESURE METHADONE SCREEN TESTSK012133LIVESURE BARBITURATES SCREEN TESTK012107LIVESURE PHENECYCLINE (PCP) SCREEN TESTSK012131LIVESURE BENZODIAZEPINES SCREEN TESTSK011610LIVESURE METHAMPHETAMINE SCREEN TESTSK011609LIVESURE AMPHETAMINE SCREEN TEST

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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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