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FDA 510(k)

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST

K-Number: K131931 · 2013-07-26

ApplicantChemtron Biotech, Inc.
Decision Date2013-07-26
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Chemtron Biotech, Inc.. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K131931. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST?

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Chemtron Biotech, Inc.. The 510(k) number is K131931.

When did CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST receive FDA 510(k) clearance?

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST received FDA 510(k) clearance on 2013-07-26, under 510(k) number K131931.

Who is the listed applicant for CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST?

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

What is the FDA product code for CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST?

The FDA product code for CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST is LCX.

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Other records listing Chemtron 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.

K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card TestK153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsK123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTK123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSK121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTSK111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD

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Related Devices (Code: LCX)

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.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health 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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