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FDA 510(k)

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

K-Number: K233581 · 2024-05-08

ApplicantOrtho Clinical Diagnostics
Decision Date2024-05-08
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2024-05-08 under approval number K233581. 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 VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack?

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack is a medical device that received FDA 510(k) clearance on 2024-05-08. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K233581.

When was VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack approved by the FDA?

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack received FDA 510(k) clearance on 2024-05-08, under approval number K233581.

What company makes VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack?

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack is DHA.

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Related Devices (Code: DHA)

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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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