Cleared Traditional

IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

K004002 · Diagnostic Products Corp. · Chemistry
Feb 2001
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K004002 is an FDA 510(k) clearance for the IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600), 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 February 14, 2001, 50 days after receiving the submission on December 26, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K004002 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2000
Decision Date February 14, 2001
Days to Decision 50 days
Submission Type Traditional
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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