Cleared Traditional

STAT PROFILE PHOX PLUS ANALYZER

K000895 · Nova Biomedical Corp. · Chemistry
Apr 2000
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K000895 is an FDA 510(k) clearance for the STAT PROFILE PHOX PLUS ANALYZER, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on April 17, 2000, 28 days after receiving the submission on March 20, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K000895 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2000
Decision Date April 17, 2000
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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