Cleared Traditional

CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM

K950186 · Miles, Inc. · Chemistry
Mar 1995
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K950186 is an FDA 510(k) clearance for the CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Miles, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 13, 1995, 55 days after receiving the submission on January 17, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K950186 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1995
Decision Date March 13, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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