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FDA 510(k)

HCG PREGNANCY ONE STEP TEST STRIP

K-Number: K934830 · 1993-12-02

ApplicantTcpi, Inc.
Decision Date1993-12-02
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG PREGNANCY ONE STEP TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Tcpi, Inc.. It received FDA 510(k) clearance on 1993-12-02 under 510(k) number K934830. 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 HCG PREGNANCY ONE STEP TEST STRIP?

HCG PREGNANCY ONE STEP TEST STRIP is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Tcpi, Inc.. The 510(k) number is K934830.

When did HCG PREGNANCY ONE STEP TEST STRIP receive FDA 510(k) clearance?

HCG PREGNANCY ONE STEP TEST STRIP received FDA 510(k) clearance on 1993-12-02, under 510(k) number K934830.

Who is the listed applicant for HCG PREGNANCY ONE STEP TEST STRIP?

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

What is the FDA product code for HCG PREGNANCY ONE STEP TEST STRIP?

The FDA product code for HCG PREGNANCY ONE STEP TEST STRIP is LCX.

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Other records listing Tcpi, 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.

K981363ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TESTK972960HEALTH CHECK URI-TEST PROTEIN IN URINEK981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TESTK980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTK951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

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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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