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FDA 510(k)

EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST

K-Number: K963231 · 1996-12-04

ApplicantExcel Scientific, Inc.
Decision Date1996-12-04
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXCEL ONESTEP URINE HCG MODULE PREGNANCY 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 1996-12-04 under 510(k) number K963231. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST?

EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1996-12-04. The listed applicant is Excel Scientific, Inc.. The 510(k) number is K963231.

When did EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST receive FDA 510(k) clearance?

EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST received FDA 510(k) clearance on 1996-12-04, under 510(k) number K963231.

Who is the listed applicant for EXCEL ONESTEP URINE HCG MODULE PREGNANCY 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 EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST?

The FDA product code for EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST is JHI.

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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 TESTK970425EZ SURE URINE DIPSTICK PREGNANCY HOME TESTK962146EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KITK962580EZ SURE ONESTEP EARLY PREGNANCY TEST

View all 8 devices →

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. 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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