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FDA 510(k)

ADVANCE(R) PREGNANCY TEST

K-Number: K914990 · 1991-12-23

ApplicantOrtho Pharmaceutical Corp.
Decision Date1991-12-23
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVANCE(R) PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Pharmaceutical Corp.. It received FDA 510(k) clearance on 1991-12-23 under 510(k) number K914990. 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(R) PREGNANCY TEST?

ADVANCE(R) PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is Ortho Pharmaceutical Corp.. The 510(k) number is K914990.

When did ADVANCE(R) PREGNANCY TEST receive FDA 510(k) clearance?

ADVANCE(R) PREGNANCY TEST received FDA 510(k) clearance on 1991-12-23, under 510(k) number K914990.

Who is the listed applicant for ADVANCE(R) PREGNANCY TEST?

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

What is the FDA product code for ADVANCE(R) PREGNANCY TEST?

The FDA product code for ADVANCE(R) PREGNANCY TEST is LCX.

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Other records listing Ortho Pharmaceutical Corp. 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.

K955648K-Y PERSONAL LUBRICANTK934516ADVANCE PREGNANCY TEST MODIFICATIONK893488PULSATILE PUMP FOR GONADORELIN ACETATEK881151MICROSCRAPEK810581FACT* HOME PREGNANCY TESTK800754NICKERSON'S MED. SELECTIVE CULTURE MEDIU

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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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