Cleared Traditional

AMMONIA ASSAY CAT. NO. 200-02 (K932556) - FDA 510(k) Clearance

Class I Chemistry device.

K932556 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Aug 1994
Decision
433d
Days
Class 1
Risk

K932556 is an FDA 510(k) clearance for the AMMONIA ASSAY CAT. NO. 200-02. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on August 2, 1994 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1065 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K932556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date August 02, 1994
Days to Decision 433 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
345d slower than avg
Panel avg: 88d · This submission: 433d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIF Enzymatic Method, Ammonia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1065
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 - JIF Enzymatic Method, Ammonia

All 29
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K932556.
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