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FDA 510(k)

ARIA II 125 I CORTISOL

K-Number: K802380 · 1980-10-31

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1980-10-31
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARIA II 125 I CORTISOL 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 1980-10-31 under 510(k) number K802380. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIA II 125 I CORTISOL?

ARIA II 125 I CORTISOL is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K802380.

When did ARIA II 125 I CORTISOL receive FDA 510(k) clearance?

ARIA II 125 I CORTISOL received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802380.

Who is the listed applicant for ARIA II 125 I CORTISOL?

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 CORTISOL?

The FDA product code for ARIA II 125 I CORTISOL is CGR.

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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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