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FDA 510(k)

ELECSYS CORTISOL CALCHECK

K-Number: K000576 · 2000-03-21

ApplicantRoche Diagnostics Corp.
Decision Date2000-03-21
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CORTISOL CALCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2000-03-21 under 510(k) number K000576. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CORTISOL CALCHECK?

ELECSYS CORTISOL CALCHECK is a medical device that received FDA 510(k) clearance on 2000-03-21. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K000576.

When did ELECSYS CORTISOL CALCHECK receive FDA 510(k) clearance?

ELECSYS CORTISOL CALCHECK received FDA 510(k) clearance on 2000-03-21, under 510(k) number K000576.

Who is the listed applicant for ELECSYS CORTISOL CALCHECK?

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

What is the FDA product code for ELECSYS CORTISOL CALCHECK?

The FDA product code for ELECSYS CORTISOL CALCHECK is JIX.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: JIX)

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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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