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FDA 510(k)

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT

K-Number: K955707 · 1996-05-02

ApplicantExcel Scientific, Inc.
Decision Date1996-05-02
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT 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 1996-05-02 under 510(k) number K955707. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT?

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Excel Scientific, Inc.. The 510(k) number is K955707.

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

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT received FDA 510(k) clearance on 1996-05-02, under 510(k) number K955707.

Who is the listed applicant for ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT?

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 ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT?

The FDA product code for ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT is DHA.

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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 TESTK963231EXCEL ONESTEP URINE HCG MODULE PREGNANCY TESTK962146EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT

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Related Devices (Code: DHA)

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.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc.

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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