Cleared Traditional

K943978 - WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS

K943978 is an FDA 510(k) clearance for WATERS PICO TAG CHEM PACK/FREE AMINO AC..., manufactured by Waters Chromatography Division. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 259-day FDA review.

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

FDA 510(k) Submission Details - K943978

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.

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 45
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