Cleared Traditional

EKTACHEM DT LDL CHOLESTEROL KIT

K955904 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry
May 1996
Decision
147d
Days
Class 1
Risk

About This 510(k) Submission

K955904 is an FDA 510(k) clearance for the EKTACHEM DT LDL CHOLESTEROL KIT, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 24, 1996, 147 days after receiving the submission on December 29, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K955904 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1995
Decision Date May 24, 1996
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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