Cleared Traditional

K984402 - SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT

K984402 is the FDA 510(k) clearance for SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT by Beckman Coulter, Inc.. It is a Class 1 Chemistry device (product code JIF) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K984402 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
51d
Days
Class 1
Risk

K984402 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 51 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K984402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1998
Decision Date January 29, 1999
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 23
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K984402.
RANDOX AMMONIA
K030873 · Randox Laboratories, Ltd. · May 2003
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · Beckman Coulter, Inc. · Dec 2000
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · Diagnostic Chemicals , Ltd. · Jun 2000
AMM
K981920 · Abbott Laboratories · Jul 1998
AMM
K981467 · Abbott Laboratories · Jun 1998
AMMONIA ASSAY CAT. NO. 200-02
K932556 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1994