Cleared Traditional

WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS (K943978) - FDA 510(k) Clearance

Class I Chemistry device.

K943978 · Waters Chromatography Division · Chemistry device
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May 1995
Decision
259d
Days
Class 1
Risk

K943978 is an FDA 510(k) clearance for the WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Waters Chromatography Division (Milford, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 259 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 Waters Chromatography Division devices

Submission Details

510(k) Number K943978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date May 02, 1995
Days to Decision 259 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 88d · This submission: 259d
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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