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FDA 510(k)

CORTISOL SYSTEM BY EIA

K-Number: K852939 · 1985-08-02

ApplicantAmerican Bioclinical, Inc.
Decision Date1985-08-02
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL SYSTEM BY EIA is the device name listed in this FDA 510(k) record. The listed applicant is American Bioclinical, Inc.. It received FDA 510(k) clearance on 1985-08-02 under 510(k) number K852939. 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 CORTISOL SYSTEM BY EIA?

CORTISOL SYSTEM BY EIA is a medical device that received FDA 510(k) clearance on 1985-08-02. The listed applicant is American Bioclinical, Inc.. The 510(k) number is K852939.

When did CORTISOL SYSTEM BY EIA receive FDA 510(k) clearance?

CORTISOL SYSTEM BY EIA received FDA 510(k) clearance on 1985-08-02, under 510(k) number K852939.

Who is the listed applicant for CORTISOL SYSTEM BY EIA?

The FDA 510(k) record lists American Bioclinical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTISOL SYSTEM BY EIA?

The FDA product code for CORTISOL SYSTEM BY EIA is CGR.

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Other records listing American Bioclinical, Inc. as applicant

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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