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FDA 510(k)

MODIFIED CEDIA(TM) CORTISOL ASSAY

K-Number: K896451 · 1989-12-12

ApplicantMicrogenics Corp.
Decision Date1989-12-12
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED CEDIA(TM) CORTISOL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1989-12-12 under 510(k) number K896451. 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 MODIFIED CEDIA(TM) CORTISOL ASSAY?

MODIFIED CEDIA(TM) CORTISOL ASSAY is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Microgenics Corp.. The 510(k) number is K896451.

When did MODIFIED CEDIA(TM) CORTISOL ASSAY receive FDA 510(k) clearance?

MODIFIED CEDIA(TM) CORTISOL ASSAY received FDA 510(k) clearance on 1989-12-12, under 510(k) number K896451.

Who is the listed applicant for MODIFIED CEDIA(TM) CORTISOL ASSAY?

The FDA 510(k) record lists Microgenics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED CEDIA(TM) CORTISOL ASSAY?

The FDA product code for MODIFIED CEDIA(TM) CORTISOL ASSAY is CGR.

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Other records listing Microgenics Corp. as applicant

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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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