Cleared Traditional

K934925 - BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA...

K934925 is an FDA 510(k) clearance for BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA..., manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JIF cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K934925 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
193d
Days
Class 1
Risk

K934925 is an FDA 510(k) clearance for the BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 193 days - an extended review 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: 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K934925

510(k) Number K934925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1993
Decision Date April 26, 1994
Days to Decision 193 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
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

JIF Device Classification - Class 1, General Controls

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 26
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K934925.
AMM
K981467 · Abbott Laboratories · Jun 1998
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
K964565 · Dade Intl., Inc. · Nov 1996
AMMONIA ASSAY CAT. NO. 200-02
K932556 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1994
ROCHE REAGENT FOR AMMONIA
K913124 · Roche Diagnostic Systems, Inc. · Aug 1991
PARAMAX AMMONIA REAGENT
K880651 · Baxter Healthcare Corp · Mar 1988
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110 · Em Diagnostic Systems, Inc. · Jul 1987