EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)

About This 510(k) Submission

K961115 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+), a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 7, 1996, 48 days after receiving the submission on March 20, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.