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FDA 510(k)

ELECSYS CA 19-9 CALCHECK

K-Number: K051185 · 2005-07-06

ApplicantRoche Diagnostics Corp.
Decision Date2005-07-06
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CA 19-9 CALCHECK 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 2005-07-06 under 510(k) number K051185. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CA 19-9 CALCHECK?

ELECSYS CA 19-9 CALCHECK is a medical device that received FDA 510(k) clearance on 2005-07-06. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K051185.

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

ELECSYS CA 19-9 CALCHECK received FDA 510(k) clearance on 2005-07-06, under 510(k) number K051185.

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

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?

The FDA product code for ELECSYS CA 19-9 CALCHECK is JJY.

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Other records listing Roche Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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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