FDA Product Code
FDA Product Code JIF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1065
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | 2019-02-08 | Traditional | PDF ↗ |
| K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | Siemens Healthcare Diagnostics | 2013-03-07 | Traditional | PDF ↗ |
| K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2013-02-15 | Traditional | PDF ↗ |
| K062316 | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-09-06 | Special | PDF ↗ |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-11-25 | Traditional | PDF ↗ |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | Diagnostic Chemicals , Ltd. | 2004-03-10 | Traditional | PDF ↗ |
| K030873 | RANDOX AMMONIA | Randox Laboratories, Ltd. | 2003-05-12 | Traditional | PDF ↗ |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | 2002-12-24 | Traditional | PDF ↗ |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-13 | Traditional | PDF ↗ |
| K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT | Beckman Coulter, Inc. | 2000-12-22 | Traditional | PDF ↗ |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 | Diagnostic Chemicals , Ltd. | 2000-06-02 | Traditional | PDF ↗ |
| K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT | Beckman Coulter, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K981920 | AMM | Abbott Laboratories | 1998-07-22 | Traditional | PDF ↗ |
| K981467 | AMM | Abbott Laboratories | 1998-06-22 | Traditional | PDF ↗ |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Trace America, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | Dade Intl., Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | Diagnostic Chemicals, Ltd. (Usa) | 1994-08-02 | Traditional | PDF ↗ |
| K934925 | BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR | Beckman Instruments, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K915707 | AMMONIA REAGENT SET | Tech Intl. Co. | 1992-02-26 | Traditional | PDF ↗ |
| K913124 | ROCHE REAGENT FOR AMMONIA | Roche Diagnostic Systems, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K880651 | PARAMAX AMMONIA REAGENT | Baxter Healthcare Corp | 1988-03-24 | Traditional | PDF ↗ |
| K872110 | EASY-TEST AMMONIA (AMON) ITEM NO. 16695 | Em Diagnostic Systems, Inc. | 1987-07-01 | Traditional | PDF ↗ |
| K870787 | ABBOTT SPECTRUM AMMONIA REAGENT | Abbott Laboratories | 1987-03-31 | Traditional | PDF ↗ |
| K870143 | AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 | Em Diagnostic Systems, Inc. | 1987-02-11 | Traditional | PDF ↗ |
| K864706 | RAICHEM(TM) AMMONIA REAGENT | Reagents Applications, Inc. | 1987-01-05 | Traditional | PDF ↗ |
| K840770 | PARAMAX AMMONIA REAGENTT | American Dade | 1984-04-04 | Traditional | PDF ↗ |
| K821719 | AMMONIA REAGENT | Gilford Diagnostics | 1982-06-24 | Traditional | PDF ↗ |
| K770363 | ACA AMMONIA ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1977-04-08 | Traditional | PDF ↗ |
| K770273 | TEST, AMMONIA, BMC REAGENTSET | Boehringer Mannheim Corp. | 1977-03-01 | Traditional | PDF ↗ |
| K760332 | SIGMA AMMONIA REAGENT | Sigma Chemical Co. | 1976-08-23 | Traditional | PDF ↗ |
Product code JIF · Class I · Clinical Chemistry. Data: openFDA.