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FDA 510(k)

ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST

K-Number: K871601 · 1987-08-26

ApplicantAdvanced Care Products
Decision Date1987-08-26
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVANCE* PREGNANCY TEST ACP 2 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 1987-08-26 under 510(k) number K871601. 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 ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST?

ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1987-08-26. The listed applicant is Advanced Care Products. The 510(k) number is K871601.

When did ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST receive FDA 510(k) clearance?

ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST received FDA 510(k) clearance on 1987-08-26, under 510(k) number K871601.

Who is the listed applicant for ADVANCE* PREGNANCY TEST ACP 2 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 ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST?

The FDA product code for ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST is LCX.

Related Clinical Trials

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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 TESTK853142OVUTIME OVULATION PREDICTOR TESTK842265ORTHO BRAND HOME PREGNANCY 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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