Cleared Traditional

PARAMAX AMMONIA AND AMMONIA BLANK REAGENT (K964565) - FDA 510(k) Clearance

Class I Chemistry device.

K964565 · Dade Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
8d
Days
Class 1
Risk

K964565 is an FDA 510(k) clearance for the PARAMAX AMMONIA AND AMMONIA BLANK REAGENT. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1996 after a review of 8 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Intl., Inc. devices

Submission Details

510(k) Number K964565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1996
Decision Date November 22, 1996
Days to Decision 8 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
80d faster than avg
Panel avg: 88d · This submission: 8d
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 K964565.
Ammonia II
K183517 · Roche Diagnostics Operations (Rdo) · Feb 2019
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · Dade Behring, Inc. · Sep 2006
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · Beckman Coulter, Inc. · Dec 2000
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402 · Beckman Coulter, Inc. · Jan 1999
AMM
K981920 · Abbott Laboratories · Jul 1998
AMM
K981467 · Abbott Laboratories · Jun 1998