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FDA 510(k)

PREGNAGEN 1-STEP PREGNANCY TEST

K-Number: K925189 · 1993-01-06

ApplicantBiogenex Laboratories
Decision Date1993-01-06
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNAGEN 1-STEP PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biogenex Laboratories. It received FDA 510(k) clearance on 1993-01-06 under 510(k) number K925189. 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 PREGNAGEN 1-STEP PREGNANCY TEST?

PREGNAGEN 1-STEP PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1993-01-06. The listed applicant is Biogenex Laboratories. The 510(k) number is K925189.

When did PREGNAGEN 1-STEP PREGNANCY TEST receive FDA 510(k) clearance?

PREGNAGEN 1-STEP PREGNANCY TEST received FDA 510(k) clearance on 1993-01-06, under 510(k) number K925189.

Who is the listed applicant for PREGNAGEN 1-STEP PREGNANCY TEST?

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

What is the FDA product code for PREGNAGEN 1-STEP PREGNANCY TEST?

The FDA product code for PREGNAGEN 1-STEP PREGNANCY TEST is LCX.

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Other records listing Biogenex Laboratories 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.

K012960BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORK013148BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)K902208MODIFIED OVUGENK884880PREGNAGEN(TM)K882002PREGNAGEN(TM)K873534OVUGEN SURETEST

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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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