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FDA 510(k)

CARDIAC T ELISA TROPONIN-T

K-Number: K924392 · 1994-04-26

ApplicantBoehringer Mannheim Corp.
Decision Date1994-04-26
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIAC T ELISA TROPONIN-T is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K924392. 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 CARDIAC T ELISA TROPONIN-T?

CARDIAC T ELISA TROPONIN-T is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K924392.

When did CARDIAC T ELISA TROPONIN-T receive FDA 510(k) clearance?

CARDIAC T ELISA TROPONIN-T received FDA 510(k) clearance on 1994-04-26, under 510(k) number K924392.

Who is the listed applicant for CARDIAC T ELISA TROPONIN-T?

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

What is the FDA product code for CARDIAC T ELISA TROPONIN-T?

The FDA product code for CARDIAC T ELISA TROPONIN-T 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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