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FDA 510(k)

LEECO CORTISOL-QUANT

K-Number: K843384 · 1984-09-28

ApplicantLeeco Diagnostics, Inc.
Decision Date1984-09-28
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO CORTISOL-QUANT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-09-28 under 510(k) number K843384. 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 LEECO CORTISOL-QUANT?

LEECO CORTISOL-QUANT is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K843384.

When did LEECO CORTISOL-QUANT receive FDA 510(k) clearance?

LEECO CORTISOL-QUANT received FDA 510(k) clearance on 1984-09-28, under 510(k) number K843384.

Who is the listed applicant for LEECO CORTISOL-QUANT?

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

What is the FDA product code for LEECO CORTISOL-QUANT?

The FDA product code for LEECO CORTISOL-QUANT is CGR.

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Other records listing Leeco Diagnostics, Inc. as applicant

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Related Devices (Code: 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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