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FDA 510(k)

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

K-Number: K970425 · 1997-03-06

ApplicantExcel Scientific, Inc.
Decision Date1997-03-06
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST is the device name listed in this FDA 510(k) record. The listed applicant is Excel Scientific, Inc.. It received FDA 510(k) clearance on 1997-03-06 under 510(k) number K970425. 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 EZ SURE URINE DIPSTICK PREGNANCY HOME TEST?

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Excel Scientific, Inc.. The 510(k) number is K970425.

When did EZ SURE URINE DIPSTICK PREGNANCY HOME TEST receive FDA 510(k) clearance?

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST received FDA 510(k) clearance on 1997-03-06, under 510(k) number K970425.

Who is the listed applicant for EZ SURE URINE DIPSTICK PREGNANCY HOME TEST?

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

What is the FDA product code for EZ SURE URINE DIPSTICK PREGNANCY HOME TEST?

The FDA product code for EZ SURE URINE DIPSTICK PREGNANCY HOME TEST is LCX.

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Other records listing Excel Scientific, 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.

K971286EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TESTK970467EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KITK970424EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TESTK963231EXCEL ONESTEP URINE HCG MODULE PREGNANCY TESTK962146EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KITK962580EZ SURE ONESTEP EARLY PREGNANCY 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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