Cleared Traditional

K060345 - NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
(FDA 510(k) Clearance)

K060345 · Nova Biomedical Corp. · Chemistry

Apr 2006

Decision

77d

Days

Class 2

Risk

K060345 is an FDA 510(k) clearance for the NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on April 28, 2006, 77 days after receiving the submission on February 10, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K060345 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2006
Decision Date	April 28, 2006
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement