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FDA 510(k)

ARIA II 125- I-ESTRIOL SYSTEM

K-Number: K801735 · 1980-09-16

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1980-09-16
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARIA II 125- I-ESTRIOL 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 1980-09-16 under 510(k) number K801735. 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 ARIA II 125- I-ESTRIOL SYSTEM?

ARIA II 125- I-ESTRIOL SYSTEM is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K801735.

When did ARIA II 125- I-ESTRIOL SYSTEM receive FDA 510(k) clearance?

ARIA II 125- I-ESTRIOL SYSTEM received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801735.

Who is the listed applicant for ARIA II 125- I-ESTRIOL 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 ARIA II 125- I-ESTRIOL SYSTEM?

The FDA product code for ARIA II 125- I-ESTRIOL 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

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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