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FDA 510(k)

ELECSYS CK-MB CALCHECK 5

K-Number: K093582 · 2010-03-29

ApplicantRoche Diagnostics
Decision Date2010-03-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CK-MB 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 2010-03-29 under 510(k) number K093582. 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 CK-MB CALCHECK 5?

ELECSYS CK-MB CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2010-03-29. The listed applicant is Roche Diagnostics. The 510(k) number is K093582.

When did ELECSYS CK-MB CALCHECK 5 receive FDA 510(k) clearance?

ELECSYS CK-MB CALCHECK 5 received FDA 510(k) clearance on 2010-03-29, under 510(k) number K093582.

Who is the listed applicant for ELECSYS CK-MB 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 CK-MB CALCHECK 5?

The FDA product code for ELECSYS CK-MB CALCHECK 5 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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