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FDA 510(k)

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY

K-Number: K880678 · 1988-04-05

ApplicantVentrex Laboratories, Inc.
Decision Date1988-04-05
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K880678. 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 MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY?

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K880678.

When did MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1988-04-05, under 510(k) number K880678.

Who is the listed applicant for MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY?

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

What is the FDA product code for MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY?

The FDA product code for MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY is DHA.

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Related Devices (Code: DHA)

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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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