CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA

About This 510(k) Submission

K120351 is an FDA 510(k) clearance for the CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on May 3, 2012, 87 days after receiving the submission on February 6, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.