Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JIF — Predicate Candidate Screening
30 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
193 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183517 | Ammonia II | Roche Diagnostics Operations (Rdo) | 2019-02-08 | 52 | 0 |
| K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMI | Siemens Healthcare Diagnostics | 2013-03-07 | 97 | 0 |
| K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2013-02-15 | 112 | 0 |
| K062316 | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-09-06 | 28 | 0 |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-11-25 | 207 | 1 |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | Diagnostic Chemicals , Ltd. | 2004-03-10 | 83 | 1 |
| K030873 | RANDOX AMMONIA | Randox Laboratories, Ltd. | 2003-05-12 | 53 | 0 |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | 2002-12-24 | 36 | 0 |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-13 | 94 | 0 |
| K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT | Beckman Coulter, Inc. | 2000-12-22 | 71 | 0 |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 26 | Diagnostic Chemicals , Ltd. | 2000-06-02 | 42 | 0 |
| K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT | Beckman Coulter, Inc. | 1999-01-29 | 51 | 1 |
| K981920 | AMM | Abbott Laboratories | 1998-07-22 | 51 | 0 |
| K981467 | AMM | Abbott Laboratories | 1998-06-22 | 60 | 0 |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Trace America, Inc. | 1998-01-02 | 22 | 1 |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | Dade Intl., Inc. | 1996-11-22 | 8 | 0 |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | Diagnostic Chemicals, Ltd. (Usa) | 1994-08-02 | 433 | 0 |
| K934925 | BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR | Beckman Instruments, Inc. | 1994-04-26 | 193 | 0 |
| K915707 | AMMONIA REAGENT SET | Tech Intl. Co. | 1992-02-26 | 89 | 0 |
| K913124 | ROCHE REAGENT FOR AMMONIA | Roche Diagnostic Systems, Inc. | 1991-08-12 | 28 | 0 |
| K880651 | PARAMAX AMMONIA REAGENT | Baxter Healthcare Corp | 1988-03-24 | 36 | 0 |
| K872110 | EASY-TEST AMMONIA (AMON) ITEM NO. 16695 | Em Diagnostic Systems, Inc. | 1987-07-01 | 30 | 0 |
| K870787 | ABBOTT SPECTRUM AMMONIA REAGENT | Abbott Laboratories | 1987-03-31 | 33 | 0 |
| K870143 | AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 | Em Diagnostic Systems, Inc. | 1987-02-11 | 29 | 0 |
| K864706 | RAICHEM(TM) AMMONIA REAGENT | Reagents Applications, Inc. | 1987-01-05 | 34 | 0 |
| K840770 | PARAMAX AMMONIA REAGENTT | American Dade | 1984-04-04 | 67 | 0 |
| K821719 | AMMONIA REAGENT | Gilford Diagnostics | 1982-06-24 | 14 | 0 |
| K770363 | ACA AMMONIA ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1977-04-08 | 44 | 0 |
| K770273 | TEST, AMMONIA, BMC REAGENTSET | Boehringer Mannheim Corp. | 1977-03-01 | 15 | 0 |
| K760332 | SIGMA AMMONIA REAGENT | Sigma Chemical Co. | 1976-08-23 | 26 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda