Cleared Traditional

DSL CK-MB (DSL #3200)

K904721 · Diagnostic Systems Laboratories, Inc. · Toxicology
Dec 1990
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K904721 is an FDA 510(k) clearance for the DSL CK-MB (DSL #3200), a Chromatographic Separation, Cpk Isoenzymes (Class II — Special Controls, product code JHT), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on December 13, 1990, 56 days after receiving the submission on October 18, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K904721 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 1990
Decision Date December 13, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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