Cleared Traditional

K973628 - VITALAB FLEXOR/VITALAB SELECTRA 2/VITAL...

K973628 is the FDA 510(k) clearance for VITALAB FLEXOR/VITALAB SELECTRA 2/VITAL... by Vital Scientific N.V.. It is a Class 1 Chemistry device (product code JJF) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K973628 · Vital Scientific N.V. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
170d
Days
Class 1
Risk

K973628 is an FDA 510(k) clearance for the VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on March 13, 1998 after a review of 170 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Vital Scientific N.V. devices

Submission Details

510(k) Number K973628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 88d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

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