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FDA 510(k)

ELECSYS CA 19-9 CALCHECK 5

K-Number: K101365 · 2010-10-05

ApplicantRoche Diagnostics Corp.
Decision Date2010-10-05
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CA 19-9 CALCHECK 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2010-10-05 under 510(k) number K101365. 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 CA 19-9 CALCHECK 5?

ELECSYS CA 19-9 CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K101365.

When did ELECSYS CA 19-9 CALCHECK 5 receive FDA 510(k) clearance?

ELECSYS CA 19-9 CALCHECK 5 received FDA 510(k) clearance on 2010-10-05, under 510(k) number K101365.

Who is the listed applicant for ELECSYS CA 19-9 CALCHECK 5?

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

What is the FDA product code for ELECSYS CA 19-9 CALCHECK 5?

The FDA product code for ELECSYS CA 19-9 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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