Cleared Traditional

AMMONIA REAGENT SET

K915707 · Tech Intl. Co. · Chemistry
Feb 1992
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K915707 is an FDA 510(k) clearance for the AMMONIA REAGENT SET, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on February 26, 1992, 89 days after receiving the submission on November 29, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K915707 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1991
Decision Date February 26, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIF — Enzymatic Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065

Similar Devices — JIF Enzymatic Method, Ammonia

All 29
Ammonia II
K183517 · Roche Diagnostics Operations (Rdo) · Feb 2019
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
K123677 · Siemens Healthcare Diagnostics · Mar 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320 · Siemens Healthcare Diagnostics · Feb 2013
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · Dade Behring, Inc. · Sep 2006
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
K051114 · Sentinel Ch. Srl · Nov 2005
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · Diagnostic Chemicals , Ltd. · Mar 2004