Cleared Traditional

NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM

K112955 · Nova Biomedical Corporation · Chemistry
Jan 2012
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K112955 is an FDA 510(k) clearance for the NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on January 5, 2012, 93 days after receiving the submission on October 4, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number K112955 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2011
Decision Date January 05, 2012
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHP — Acid, Lactic, Enzymatic Method
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1450

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