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FDA 510(k)

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST

K-Number: K022946 · 2002-10-08

ApplicantPrinceton BioMeditech Corp.
Decision Date2002-10-08
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K022946. 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 LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST?

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K022946.

When did LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST receive FDA 510(k) clearance?

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST received FDA 510(k) clearance on 2002-10-08, under 510(k) number K022946.

Who is the listed applicant for LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST?

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

What is the FDA product code for LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST?

The FDA product code for LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST 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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