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FDA 510(k)

ELECSYS ANTI-TSHR CALCHECK

K-Number: K080643 · 2008-08-22

ApplicantRoche Diagnostics
Decision Date2008-08-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS ANTI-TSHR CALCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K080643. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS ANTI-TSHR CALCHECK?

ELECSYS ANTI-TSHR CALCHECK is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Roche Diagnostics. The 510(k) number is K080643.

When did ELECSYS ANTI-TSHR CALCHECK receive FDA 510(k) clearance?

ELECSYS ANTI-TSHR CALCHECK received FDA 510(k) clearance on 2008-08-22, under 510(k) number K080643.

Who is the listed applicant for ELECSYS ANTI-TSHR CALCHECK?

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 ELECSYS ANTI-TSHR CALCHECK?

The FDA product code for ELECSYS ANTI-TSHR CALCHECK is JJX.

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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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