Cleared Special

IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)

K022118 · Diagnostic Products Corp. · Chemistry
Jul 2002
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K022118 is an FDA 510(k) clearance for the IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS), 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 July 22, 2002, 21 days after receiving the submission on July 1, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K022118 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2002
Decision Date July 22, 2002
Days to Decision 21 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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