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FDA 510(k)

ELECYSYS SHBG

K-Number: K102814 · 2011-01-20

ApplicantRoche Diagnostics
Decision Date2011-01-20
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECYSYS SHBG is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2011-01-20 under 510(k) number K102814. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECYSYS SHBG?

ELECYSYS SHBG is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Roche Diagnostics. The 510(k) number is K102814.

When did ELECYSYS SHBG receive FDA 510(k) clearance?

ELECYSYS SHBG received FDA 510(k) clearance on 2011-01-20, under 510(k) number K102814.

Who is the listed applicant for ELECYSYS SHBG?

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

What is the FDA product code for ELECYSYS SHBG?

The FDA product code for ELECYSYS SHBG is CDZ.

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Related Devices (Code: CDZ)

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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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