Cleared Traditional

K811573 - CARDIOZYME PLUS CK-MB ITEM #65045
(FDA 510(k) Clearance)

K811573 · Harleco · Chemistry
Jun 1981
Decision
21d
Days
Class 2
Risk

K811573 is an FDA 510(k) clearance for the CARDIOZYME PLUS CK-MB ITEM #65045. This device is classified as a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW).

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on June 25, 1981, 21 days after receiving the submission on June 4, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K811573 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1981
Decision Date June 25, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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