Cleared Traditional

K961209 - BRIO AUTOMATIC SAMPLINC UNIT

K961209 is an FDA 510(k) clearance for BRIO AUTOMATIC SAMPLINC UNIT, manufactured by Seac S.R.L.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K961209 · Seac S.R.L. · Chemistry device
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Dec 1996
Decision
271d
Days
Class 1
Risk

K961209 is an FDA 510(k) clearance for the BRIO AUTOMATIC SAMPLINC UNIT. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Seac S.R.L. (Newton, US). The FDA issued a Cleared decision on December 24, 1996 after a review of 271 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 Seac S.R.L. devices

FDA 510(k) Submission Details - K961209

510(k) Number K961209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1996
Decision Date December 24, 1996
Days to Decision 271 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 88d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

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

All 44
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