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FDA 510(k)

HOME PREGNANCY TEST KIT

K-Number: K831108 · 1983-05-18

ApplicantQuidel Corp.
Decision Date1983-05-18
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HOME PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1983-05-18 under 510(k) number K831108. 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 HOME PREGNANCY TEST KIT?

HOME PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1983-05-18. The listed applicant is Quidel Corp.. The 510(k) number is K831108.

When did HOME PREGNANCY TEST KIT receive FDA 510(k) clearance?

HOME PREGNANCY TEST KIT received FDA 510(k) clearance on 1983-05-18, under 510(k) number K831108.

Who is the listed applicant for HOME PREGNANCY TEST KIT?

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

What is the FDA product code for HOME PREGNANCY TEST KIT?

The FDA product code for HOME PREGNANCY TEST KIT is LCX.

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Other records listing Quidel Corp. as applicant

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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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