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FDA 510(k)

ABBOTT AXSYM TROPONIN-I ADV

K-Number: K041811 · 2004-09-10

ApplicantAbbott Laboratories
Decision Date2004-09-10
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT AXSYM TROPONIN-I ADV is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2004-09-10 under 510(k) number K041811. 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 ABBOTT AXSYM TROPONIN-I ADV?

ABBOTT AXSYM TROPONIN-I ADV is a medical device that received FDA 510(k) clearance on 2004-09-10. The listed applicant is Abbott Laboratories. The 510(k) number is K041811.

When did ABBOTT AXSYM TROPONIN-I ADV receive FDA 510(k) clearance?

ABBOTT AXSYM TROPONIN-I ADV received FDA 510(k) clearance on 2004-09-10, under 510(k) number K041811.

Who is the listed applicant for ABBOTT AXSYM TROPONIN-I ADV?

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

What is the FDA product code for ABBOTT AXSYM TROPONIN-I ADV?

The FDA product code for ABBOTT AXSYM TROPONIN-I ADV is MMI.

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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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