Cleared Traditional

K821719 - AMMONIA REAGENT

K821719 is the FDA 510(k) clearance for AMMONIA REAGENT by Gilford Diagnostics. It is a Class 1 Microbiology device (product code JIF) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821719 · Gilford Diagnostics · Microbiology device
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Jun 1982
Decision
14d
Days
Class 1
Risk

K821719 is an FDA 510(k) clearance for the AMMONIA REAGENT. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1065 - the FDA microbiology device 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 Gilford Diagnostics devices

Submission Details

510(k) Number K821719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1982
Decision Date June 24, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
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 K821719.
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143 · Em Diagnostic Systems, Inc. · Feb 1987
RAICHEM(TM) AMMONIA REAGENT
K864706 · Reagents Applications, Inc. · Jan 1987
PARAMAX AMMONIA REAGENTT
K840770 · American Dade · Apr 1984
ACA AMMONIA ANALYTICAL TEST PACK
K770363 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1977
TEST, AMMONIA, BMC REAGENTSET
K770273 · Boehringer Mannheim Corp. · Mar 1977
SIGMA AMMONIA REAGENT
K760332 · Sigma Chemical Co. · Aug 1976