Cleared Traditional

K870143 - AMMONIA (AMON) TESTPACK

K870143 is the FDA 510(k) clearance for AMMONIA (AMON) TESTPACK by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JIF) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K870143 · Em Diagnostic Systems, Inc. · Chemistry device
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Feb 1987
Decision
29d
Days
Class 1
Risk

K870143 is an FDA 510(k) clearance for the AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 11, 1987 after a review of 29 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K870143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1987
Decision Date February 11, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K870143.
PARAMAX AMMONIA REAGENT
K880651 · Baxter Healthcare Corp · Mar 1988
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110 · Em Diagnostic Systems, Inc. · Jul 1987
ABBOTT SPECTRUM AMMONIA REAGENT
K870787 · Abbott Laboratories · Mar 1987
RAICHEM(TM) AMMONIA REAGENT
K864706 · Reagents Applications, Inc. · Jan 1987
PARAMAX AMMONIA REAGENTT
K840770 · American Dade · Apr 1984
AMMONIA REAGENT
K821719 · Gilford Diagnostics · Jun 1982