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FDA 510(k)

RIA-120 AND ESTRIOL REAGENT SYSTEM

K-Number: K770465 · 1977-06-02

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-06-02
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA-120 AND ESTRIOL REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1977-06-02 under 510(k) number K770465. The device is classified under product code CGI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIA-120 AND ESTRIOL REAGENT SYSTEM?

RIA-120 AND ESTRIOL REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1977-06-02. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K770465.

When did RIA-120 AND ESTRIOL REAGENT SYSTEM receive FDA 510(k) clearance?

RIA-120 AND ESTRIOL REAGENT SYSTEM received FDA 510(k) clearance on 1977-06-02, under 510(k) number K770465.

Who is the listed applicant for RIA-120 AND ESTRIOL REAGENT SYSTEM?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIA-120 AND ESTRIOL REAGENT SYSTEM?

The FDA product code for RIA-120 AND ESTRIOL REAGENT SYSTEM is CGI.

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Related Devices (Code: CGI)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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