Cleared Traditional

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

K973628 · Vital Scientific N.V. · Chemistry
Mar 1998
Decision
170d
Days
Class 1
Risk

About This 510(k) Submission

K973628 is an FDA 510(k) clearance for the VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on March 13, 1998, 170 days after receiving the submission on September 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K973628 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1997
Decision Date March 13, 1998
Days to Decision 170 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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