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FDA 510(k)

ELECSYS TROPONIN T STAT TEST

K-Number: K040733 · 2004-05-17

ApplicantRoche Diagnostics Corp.
Decision Date2004-05-17
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS TROPONIN T STAT TEST 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 2004-05-17 under 510(k) number K040733. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS TROPONIN T STAT TEST?

ELECSYS TROPONIN T STAT TEST is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K040733.

When did ELECSYS TROPONIN T STAT TEST receive FDA 510(k) clearance?

ELECSYS TROPONIN T STAT TEST received FDA 510(k) clearance on 2004-05-17, under 510(k) number K040733.

Who is the listed applicant for ELECSYS TROPONIN T STAT TEST?

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 TROPONIN T STAT TEST?

The FDA product code for ELECSYS TROPONIN T STAT TEST is MMI.

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Other records listing Roche Diagnostics Corp. as applicant

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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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