Cleared Traditional

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST

K022946 · Princeton BioMeditech Corp. · Chemistry
Oct 2002
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K022946 is an FDA 510(k) clearance for the LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on October 8, 2002, 34 days after receiving the submission on September 4, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K022946 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2002
Decision Date October 08, 2002
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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