Cleared Traditional

NOVA 16 ANALYZER

K945584 · Nova Biomedical Corp. · Chemistry

Feb 1995

Decision

86d

Days

Class 1

Risk

About This 510(k) Submission

K945584 is an FDA 510(k) clearance for the NOVA 16 ANALYZER, a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I — General Controls, product code JJC), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on February 8, 1995, 86 days after receiving the submission on November 14, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2150.

Submission Details

510(k) Number	K945584 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 1994
Decision Date	February 08, 1995
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

Product Code	JJC — Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2150