JIF · Enzymatic Method, Ammonia
Clinical Chemistry · 21 CFR 862.1065 · Class 1
Overview
| Product Code | JIF |
|---|---|
| Device Name | Enzymatic Method, Ammonia |
| Regulation | 21 CFR 862.1065 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
Classification Rationale
Class I.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | Feb 8, 2019 | SESE |
| K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | Siemens Healthcare Diagnostics | Mar 7, 2013 | SESE |
| K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | Feb 15, 2013 | SESE |
| K062316 | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Sep 6, 2006 | SESE |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | Sentinel Ch. Srl | Nov 25, 2005 | SESE |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | Diagnostic Chemicals , Ltd. | Mar 10, 2004 | SESE |
| K030873 | RANDOX AMMONIA | Randox Laboratories, Ltd. | May 12, 2003 | SESE |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | Dec 24, 2002 | SESE |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Jul 13, 2002 | SESE |
| K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT | Beckman Coulter, Inc. | Dec 22, 2000 | SESE |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 | Diagnostic Chemicals , Ltd. | Jun 2, 2000 | SESE |
| K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT | Beckman Coulter, Inc. | Jan 29, 1999 | SESE |
| K981920 | AMM | Abbott Laboratories | Jul 22, 1998 | SESE |
| K981467 | AMM | Abbott Laboratories | Jun 22, 1998 | SESE |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Trace America, Inc. | Jan 2, 1998 | SESE |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | Dade Intl., Inc. | Nov 22, 1996 | SESE |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | Diagnostic Chemicals, Ltd. (Usa) | Aug 2, 1994 | SESE |
| K934925 | BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR | Beckman Instruments, Inc. | Apr 26, 1994 | SESE |
| K915707 | AMMONIA REAGENT SET | Tech Intl. Co. | Feb 26, 1992 | SESE |
| K913124 | ROCHE REAGENT FOR AMMONIA | Roche Diagnostic Systems, Inc. | Aug 12, 1991 | SESE |
Top Applicants
- Abbott Laboratories — 3 clearances
- Bayer Diagnostics Corp. — 2 clearances
- Beckman Coulter, Inc. — 2 clearances
- Diagnostic Chemicals , Ltd. — 2 clearances
- Em Diagnostic Systems, Inc. — 2 clearances
