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FDA 510(k)

VENTRE/SEP CORTISOL RIA

K-Number: K800594 · 1980-04-04

ApplicantVentrex Laboratories, Inc.
Decision Date1980-04-04
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTRE/SEP CORTISOL RIA 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 1980-04-04 under 510(k) number K800594. 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 VENTRE/SEP CORTISOL RIA?

VENTRE/SEP CORTISOL RIA is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K800594.

When did VENTRE/SEP CORTISOL RIA receive FDA 510(k) clearance?

VENTRE/SEP CORTISOL RIA received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800594.

Who is the listed applicant for VENTRE/SEP CORTISOL RIA?

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 VENTRE/SEP CORTISOL RIA?

The FDA product code for VENTRE/SEP CORTISOL RIA 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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