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FDA 510(k)

CASSETTE/URINE HCG

K-Number: K023638 · 2003-01-03

ApplicantInd Diagnostic, Inc.
Decision Date2003-01-03
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CASSETTE/URINE HCG is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostic, Inc.. It received FDA 510(k) clearance on 2003-01-03 under 510(k) number K023638. 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 CASSETTE/URINE HCG?

CASSETTE/URINE HCG is a medical device that received FDA 510(k) clearance on 2003-01-03. The listed applicant is Ind Diagnostic, Inc.. The 510(k) number is K023638.

When did CASSETTE/URINE HCG receive FDA 510(k) clearance?

CASSETTE/URINE HCG received FDA 510(k) clearance on 2003-01-03, under 510(k) number K023638.

Who is the listed applicant for CASSETTE/URINE HCG?

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

What is the FDA product code for CASSETTE/URINE HCG?

The FDA product code for CASSETTE/URINE HCG is LCX.

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Other records listing Ind Diagnostic, 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.

K103037IND URINARY TRACT INFECTION (UTI) TEST STRIPSK100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10K063390URINE CHEMISTRY ANALYZER UR-50K060810ONE STEP DRUG TEST - AMP/MET/MOR/THC/COCK052694ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.K052662ONE STEP FSH MENOPAUSAL 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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