Cleared Traditional

COULTER CK-MB ISOENZYME REAGENT

K904866 · Coulter Electronics, Inc. · Chemistry
Dec 1990
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K904866 is an FDA 510(k) clearance for the COULTER CK-MB ISOENZYME REAGENT, a Chromatographic Separation, Cpk Isoenzymes (Class II — Special Controls, product code JHT), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on December 13, 1990, 45 days after receiving the submission on October 29, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K904866 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1990
Decision Date December 13, 1990
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHT — Chromatographic Separation, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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