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FDA 510(k)

CORTISOL ELISA

K-Number: K062626 · 2006-12-20

ApplicantIbl-Hamburg GmbH
Decision Date2006-12-20
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Ibl-Hamburg GmbH. It received FDA 510(k) clearance on 2006-12-20 under 510(k) number K062626. 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 ELISA?

CORTISOL ELISA is a medical device that received FDA 510(k) clearance on 2006-12-20. The listed applicant is Ibl-Hamburg GmbH. The 510(k) number is K062626.

When did CORTISOL ELISA receive FDA 510(k) clearance?

CORTISOL ELISA received FDA 510(k) clearance on 2006-12-20, under 510(k) number K062626.

Who is the listed applicant for CORTISOL ELISA?

The FDA 510(k) record lists Ibl-Hamburg GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTISOL ELISA?

The FDA product code for CORTISOL ELISA 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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