Cleared Traditional

IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)

K981495 · Diagnostic Products Corp. · Chemistry
Jun 1998
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K981495 is an FDA 510(k) clearance for the IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS), a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHS), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 10, 1998, 44 days after receiving the submission on April 27, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K981495 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1998
Decision Date June 10, 1998
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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