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FDA 510(k)

ABBOTT AXSYM TROPONIN-I

K-Number: K974103 · 1997-11-25

ApplicantAbbott Laboratories
Decision Date1997-11-25
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT AXSYM TROPONIN-I is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1997-11-25 under 510(k) number K974103. 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?

ABBOTT AXSYM TROPONIN-I is a medical device that received FDA 510(k) clearance on 1997-11-25. The listed applicant is Abbott Laboratories. The 510(k) number is K974103.

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

ABBOTT AXSYM TROPONIN-I received FDA 510(k) clearance on 1997-11-25, under 510(k) number K974103.

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

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?

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

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Related Devices (Code: MMI)

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.

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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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