Cleared Traditional

NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

K070068 · Nova Biomedical Corp. · Chemistry
May 2007
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K070068 is an FDA 510(k) clearance for the NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS, a Electrode, Ion Based, Enzymatic, Creatinine (Class II — Special Controls, product code CGL), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on May 7, 2007, 119 days after receiving the submission on January 8, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K070068 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2007
Decision Date May 07, 2007
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGL — Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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