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FDA 510(k)

ELECSYS T3 CALCHECK 5

K-Number: K111552 · 2011-07-21

ApplicantRoche Diagnostics
Decision Date2011-07-21
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS T3 CALCHECK 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2011-07-21 under 510(k) number K111552. 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 T3 CALCHECK 5?

ELECSYS T3 CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is Roche Diagnostics. The 510(k) number is K111552.

When did ELECSYS T3 CALCHECK 5 receive FDA 510(k) clearance?

ELECSYS T3 CALCHECK 5 received FDA 510(k) clearance on 2011-07-21, under 510(k) number K111552.

Who is the listed applicant for ELECSYS T3 CALCHECK 5?

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 T3 CALCHECK 5?

The FDA product code for ELECSYS T3 CALCHECK 5 is JJX.

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Related Devices (Code: 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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