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FDA 510(k)

ELECSYS T4 CALCHECK 5

K-Number: K112528 · 2011-10-18

ApplicantRoche Diagnostics Corporation
Decision Date2011-10-18
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS T4 CALCHECK 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corporation. It received FDA 510(k) clearance on 2011-10-18 under 510(k) number K112528. 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 T4 CALCHECK 5?

ELECSYS T4 CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2011-10-18. The listed applicant is Roche Diagnostics Corporation. The 510(k) number is K112528.

When did ELECSYS T4 CALCHECK 5 receive FDA 510(k) clearance?

ELECSYS T4 CALCHECK 5 received FDA 510(k) clearance on 2011-10-18, under 510(k) number K112528.

Who is the listed applicant for ELECSYS T4 CALCHECK 5?

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

What is the FDA product code for ELECSYS T4 CALCHECK 5?

The FDA product code for ELECSYS T4 CALCHECK 5 is JJX.

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Official Source

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