Product code JIF
- Device name
- Enzymatic Method, Ammonia
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1065
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | 2019-02-08 |
| K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | Siemens Healthcare Diagnostics | 2013-03-07 |
| K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2013-02-15 |
| K062316 | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-09-06 |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-11-25 |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | Diagnostic Chemicals , Ltd. | 2004-03-10 |
| K030873 | RANDOX AMMONIA | Randox Laboratories, Ltd. | 2003-05-12 |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | 2002-12-24 |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-13 |
| K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT | Beckman Coulter, Inc. | 2000-12-22 |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 | Diagnostic Chemicals , Ltd. | 2000-06-02 |
| K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT | Beckman Coulter, Inc. | 1999-01-29 |
| K981920 | AMM | Abbott Laboratories | 1998-07-22 |
| K981467 | AMM | Abbott Laboratories | 1998-06-22 |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Trace America, Inc. | 1998-01-02 |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | Dade Intl., Inc. | 1996-11-22 |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | Diagnostic Chemicals, Ltd. (Usa) | 1994-08-02 |
| K934925 | BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR | Beckman Instruments, Inc. | 1994-04-26 |
| K915707 | AMMONIA REAGENT SET | Tech Intl. Co. | 1992-02-26 |
| K913124 | ROCHE REAGENT FOR AMMONIA | Roche Diagnostic Systems, Inc. | 1991-08-12 |
| K880651 | PARAMAX AMMONIA REAGENT | Baxter Healthcare Corp | 1988-03-24 |
| K872110 | EASY-TEST AMMONIA (AMON) ITEM NO. 16695 | Em Diagnostic Systems, Inc. | 1987-07-01 |
| K870787 | ABBOTT SPECTRUM AMMONIA REAGENT | Abbott Laboratories | 1987-03-31 |
| K870143 | AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 | Em Diagnostic Systems, Inc. | 1987-02-11 |
| K864706 | RAICHEM(TM) AMMONIA REAGENT | Reagents Applications, Inc. | 1987-01-05 |
| K840770 | PARAMAX AMMONIA REAGENTT | American Dade | 1984-04-04 |
| K821719 | AMMONIA REAGENT | Gilford Diagnostics | 1982-06-24 |
| K770363 | ACA AMMONIA ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1977-04-08 |
| K770273 | TEST, AMMONIA, BMC REAGENTSET | Boehringer Mannheim Corp. | 1977-03-01 |
| K760332 | SIGMA AMMONIA REAGENT | Sigma Chemical Co. | 1976-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00845275000016 | Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers | Fisher Diagnostics | 2025-11-18 |
| 08058056680181 | Ammonia Ultra | SENTINEL CH. SPA | 2023-11-22 |
| 04015630914708 | Ammonia | Roche Diagnostics GmbH | 2021-02-08 |
| 04015630927005 | Ammonia | Roche Diagnostics GmbH | 2021-02-08 |
| 04015630928071 | Ammonia | Roche Diagnostics GmbH | 2021-02-08 |
| 00630414555898 | ADVIA® Chemistry AMM Ammonia Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414595832 | Atellica CH Amm | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414948102 | Dimension Vista® Flex® reagent cartridge AMM | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414948096 | Dimension® Flex® reagent cartridge AMM | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 07613336121429 | Ammonia II | Roche Diagnostics GmbH | 2020-03-05 |
| 05055273200256 | AMMONIA (NH3) | RANDOX LABORATORIES LIMITED | 2019-06-04 |
| 05055273200263 | AMMONIA (NH3) | RANDOX LABORATORIES LIMITED | 2019-06-04 |
| 04015630936533 | Ammonia II | Roche Diagnostics GmbH | 2019-05-10 |
| 04015630936526 | Ammonia II | Roche Diagnostics GmbH | 2019-03-26 |
| 05055273200270 | NH3 | RANDOX LABORATORIES LIMITED | 2018-12-24 |
| 00817238011247 | Ammonia Standard | CLINIQA CORPORATION | 2018-08-23 |
| 00817238011438 | Ammonia Reagent | CLINIQA CORPORATION | 2018-08-23 |
| 00380740010775 | ARCHITECT | ABBOTT LABORATORIES | 2018-07-31 |
| 00380740010768 | ARCHITECT | ABBOTT LABORATORIES | 2018-07-31 |
| 00380740136192 | Alinity | ABBOTT LABORATORIES | 2018-07-30 |
| 00628063400010 | Ammonia L3K | SEKISUI DIAGNOSTICS, LLC | 2016-09-16 |
| 00845275005400 | Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems | Fisher Diagnostics | 2016-09-16 |
| 00811727010254 | POINTE SCIENTIFIC AMMONIA | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010261 | POINTE SCIENTIFIC Ammonia Standard 1 | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010278 | POINTE SCIENTIFIC Ammonia Standard 5 | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010247 | POINTE SCIENTIFIC AMMONIA | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 15099590222635 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |