Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DKJ — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
145 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093939 | ADVIA CHEMISTRY SALICYLATE REAGENT | Siemens Healthcare Diagnostics | 2010-05-19 | 148 | 0 |
| K042329 | SALICYLATE-SL ASSAY | Diagnostic Chemicals , Ltd. | 2004-12-27 | 122 | 1 |
| K020794 | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-11 | 122 | 0 |
| K014173 | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | 2002-02-15 | 57 | 1 |
| K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SA | Syva Co. | 2001-08-13 | 59 | 0 |
| K981872 | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | Diagnostic Chemicals , Ltd. | 1998-06-29 | 32 | 0 |
| K980032 | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | Diagnostic Chemicals , Ltd. | 1998-03-02 | 56 | 0 |
| K964715 | PARAMAX SALICYLATE REAGENT | Dade Intl., Inc. | 1997-04-25 | 151 | 0 |
| K961131 | SALICYLATE ASSAY | Diagnostic Reagents, Inc. | 1996-04-29 | 39 | 1 |
| K951290 | AXSYM SALICYLATE | Abbott Laboratories | 1995-08-08 | 140 | 0 |
| K946000 | ABUSCREEN ONLINE(R) CALIBRATORS | Roche Diagnostic Systems, Inc. | 1995-01-25 | 50 | 0 |
| K904301 | DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-11-09 | 51 | 0 |
| K902356 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) | Eastman Kodak Company | 1990-07-16 | 48 | 1 |
| K882038 | GDS ENZYMATIC SALICYLATE REAGENT | Gds Technology, LLC | 1988-06-24 | 39 | 0 |
| K873425 | EASY-TEST SALICYLATE (SAL) #16691 | Em Diagnostic Systems, Inc. | 1987-10-29 | 65 | 0 |
| K872321 | EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 | Em Diagnostic Systems, Inc. | 1987-08-28 | 72 | 0 |
| K872330 | EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 | Em Diagnostic Systems, Inc. | 1987-07-09 | 22 | 0 |
| K870336 | SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 | Diagnostic Chemicals, Ltd. (Usa) | 1987-02-20 | 23 | 0 |
| K861615 | SALICYLATE REAGENT SET | Sterling Diagnostics, Inc. | 1986-05-23 | 24 | 0 |
| K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-05-29 | 21 | 0 |
| K844070 | TDX SALICYLATE | Abbott Laboratories | 1984-11-27 | 40 | 1 |
| K842158 | SALICYLATE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-10-22 | 145 | 0 |
| K843180 | SALICYLATE TEST | Sclavo, Inc. | 1984-09-07 | 25 | 0 |
| K840243 | DETERMIN. OF SALICYLATE IN SERUM/PLAST | Sigma Chemical Co. | 1984-03-23 | 63 | 0 |
| K833003 | PARAMAX SALICYLATE REAGENT | American Dade | 1983-10-28 | 77 | 0 |
| K831336 | SALICYLATE ASSAY KIT | Quantimetrix Corp. | 1983-07-07 | 73 | 0 |
| K823523 | TOXI-LAB RAPID SCREEN | Marion Laboratories, Inc. | 1983-01-14 | 46 | 0 |
| K813431 | SALICYLATES | Bio-Analytics Laboratories, Inc. | 1982-03-25 | 107 | 0 |
| K813185 | SALICYLATE STAT-PAK | Clin Tech Diagnostics Corp. | 1981-11-24 | 8 | 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