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FDA 510(k)

ORTHO BRAND HOME PREGNANCY TEST

K-Number: K842265 · 1984-07-17

ApplicantAdvanced Care Products
Decision Date1984-07-17
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORTHO BRAND HOME PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Care Products. It received FDA 510(k) clearance on 1984-07-17 under 510(k) number K842265. 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 ORTHO BRAND HOME PREGNANCY TEST?

ORTHO BRAND HOME PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1984-07-17. The listed applicant is Advanced Care Products. The 510(k) number is K842265.

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

ORTHO BRAND HOME PREGNANCY TEST received FDA 510(k) clearance on 1984-07-17, under 510(k) number K842265.

Who is the listed applicant for ORTHO BRAND HOME PREGNANCY TEST?

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

What is the FDA product code for ORTHO BRAND HOME PREGNANCY TEST?

The FDA product code for ORTHO BRAND HOME PREGNANCY TEST is LCX.

Related Clinical Trials

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.

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Other records listing Advanced Care Products 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.

K945846ADVANCE(R) PREGNANCY TESTK880472ADVANCE* AND DAISY* PREGNANCY TESTK871601ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TESTK853142OVUTIME OVULATION PREDICTOR TESTK834270ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST

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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