Cleared Special

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I

K034055 · Diagnostic Products Corp. · Chemistry
Jan 2004
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K034055 is an FDA 510(k) clearance for the IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 21, 2004, 22 days after receiving the submission on December 30, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K034055 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2003
Decision Date January 21, 2004
Days to Decision 22 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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