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FDA 510(k)

FIRST RESPONSE 5 MINUTE PREGNANCY TEST

K-Number: K874823 · 1988-04-05

ApplicantTambrands, Inc.
Decision Date1988-04-05
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIRST RESPONSE 5 MINUTE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tambrands, Inc.. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K874823. 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 FIRST RESPONSE 5 MINUTE PREGNANCY TEST?

FIRST RESPONSE 5 MINUTE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Tambrands, Inc.. The 510(k) number is K874823.

When did FIRST RESPONSE 5 MINUTE PREGNANCY TEST receive FDA 510(k) clearance?

FIRST RESPONSE 5 MINUTE PREGNANCY TEST received FDA 510(k) clearance on 1988-04-05, under 510(k) number K874823.

Who is the listed applicant for FIRST RESPONSE 5 MINUTE PREGNANCY TEST?

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

What is the FDA product code for FIRST RESPONSE 5 MINUTE PREGNANCY TEST?

The FDA product code for FIRST RESPONSE 5 MINUTE PREGNANCY TEST is LCX.

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Other records listing Tambrands, 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.

K962476UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATORK960341TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUSK952344SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUSK944834UNSCENTED MENSTRUAL TAMPONSK923932TAMPAX TAMPONS, SUPER ABSORBENCYK924303TAMPAX TAMPON, REGULAR ABSORBENCY

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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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