Product Code: JIF
FDA class 1
21 CFR 862.1065
Enzymatic Method, Ammonia
Clinical Chemistry
Enzymatic Method for Ammonia is a clinical chemistry test system that uses enzymatic reactions, typically glutamate dehydrogenase-based, to measure ammonia concentration in blood, supporting diagnosis and monitoring of liver disease and urea cycle disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JIF, regulated under 21 CFR 862.1065, within the Clinical Chemistry medical specialty. This device is eligible for third-party review where applicable.
510(k)s
30
FEI Numbers
19
Registration Numbers
19
Unique Applicants
23
Years Active
42
Basic Information
- Product Code
- JIF
- Device Class
- FDA class 1
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 30 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183517 | Ammonia II | Feb 08, 2019 | Substantially Equivalent | Roche Diagnostics Operations (RDO) |
| K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | Mar 07, 2013 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS |
| K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | Feb 15, 2013 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS |
| K062316 | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE | Sep 06, 2006 | Substantially Equivalent | DADE BEHRING, INC. |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | Nov 25, 2005 | Substantially Equivalent | SENTINEL CH. SRL |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | Mar 10, 2004 | Substantially Equivalent | DIAGNOSTIC CHEMICALS LTD. |
| K030873 | RANDOX AMMONIA | May 12, 2003 | Substantially Equivalent | RANDOX LABORATORIES, LTD. |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Dec 24, 2002 | Substantially Equivalent | BAYER DIAGNOSTICS CORP. |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Jul 13, 2002 | Substantially Equivalent | BAYER DIAGNOSTICS CORP. |
| K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT | Dec 22, 2000 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 | Jun 02, 2000 | Substantially Equivalent | DIAGNOSTIC CHEMICALS LTD. |
| K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT | Jan 29, 1999 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K981920 | AMM | Jul 22, 1998 | Substantially Equivalent | ABBOTT LABORATORIES |
| K981467 | AMM | Jun 22, 1998 | Substantially Equivalent | ABBOTT LABORATORIES |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Jan 02, 1998 | Substantially Equivalent | TRACE AMERICA, INC. |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | Nov 22, 1996 | Substantially Equivalent | DADE INTL., INC. |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | Aug 02, 1994 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K934925 | BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR | Apr 26, 1994 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K915707 | AMMONIA REAGENT SET | Feb 26, 1992 | Substantially Equivalent | TECH INTL. CO. |
| K913124 | ROCHE REAGENT FOR AMMONIA | Aug 12, 1991 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K880651 | PARAMAX AMMONIA REAGENT | Mar 24, 1988 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K872110 | EASY-TEST AMMONIA (AMON) ITEM NO. 16695 | Jul 01, 1987 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K870787 | ABBOTT SPECTRUM AMMONIA REAGENT | Mar 31, 1987 | Substantially Equivalent | ABBOTT LABORATORIES |
| K870143 | AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 | Feb 11, 1987 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K864706 | RAICHEM(TM) AMMONIA REAGENT | Jan 05, 1987 | Substantially Equivalent | REAGENTS APPLICATIONS, INC. |
| K840770 | PARAMAX AMMONIA REAGENTT | Apr 04, 1984 | Substantially Equivalent | AMERICAN DADE |
| K821719 | AMMONIA REAGENT | Jun 24, 1982 | Substantially Equivalent | GILFORD DIAGNOSTICS |
| K770363 | ACA AMMONIA ANALYTICAL TEST PACK | Apr 08, 1977 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K770273 | TEST, AMMONIA, BMC REAGENTSET | Mar 01, 1977 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K760332 | SIGMA AMMONIA REAGENT | Aug 23, 1976 | Substantially Equivalent | SIGMA CHEMICAL CO. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.