Colorimetry, Salicylate
FDA product code DKJ · Class II (moderate risk) · 21 CFR 862.3830 · Clinical Toxicology
29510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Diagnostic Chemicals , Ltd. 3
- Em Diagnostic Systems, Inc. 3
- Diagnostic Chemicals, Ltd. (Usa) 2
- Abbott Laboratories 2
- Sterling Diagnostics, Inc. 1
- Siemens Healthcare Diagnostics, Inc. 1
- Syva Co. 1
- Dade Intl., Inc. 1
- Diagnostic Reagents, Inc. 1
- Roche Diagnostic Systems, Inc. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- Eastman Kodak Company 1
- Gds Technology, LLC 1
- Clin Tech Diagnostics Corp. 1
- Advanced Biomedical Methods, Inc. 1
- Sclavo, Inc. 1
- Sigma Chemical Co. 1
- American Dade 1
- Quantimetrix Corp. 1
- Marion Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093939 | Advia Chemistry Salicylate ReagentDKJ · Traditional | Siemens Healthcare Diagnostics | 05/19/2010SE |
| K042329 | Salicylate-Sl AssayDKJ · Traditional | Diagnostic Chemicals , Ltd. | 12/27/2004SE |
| K020794 | Salicylate Assay for the Advia Integrated Modular SystemDKJ · Traditional | Bayer Diagnostics Corp. | 07/11/2002SE |
| K014173 | Synchron Systems Salicylate Reagent and CalibratorDKJ · Traditional | Beckman Coulter, Inc. | 02/15/2002SE |
| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | Syva Co. | 08/13/2001SE |
| K981872 | Salicylate-Sl Assay Catalogue Number 511-20,511-40DKJ · Traditional | Diagnostic Chemicals , Ltd. | 06/29/1998SE |
| K980032 | Salicylate Assay (Ace), Catalogue Number 501-71DKJ · Traditional | Diagnostic Chemicals , Ltd. | 03/02/1998SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | Dade Intl., Inc. | 04/25/1997SE |
| K961131 | Salicylate AssayDKJ · Traditional | Diagnostic Reagents, Inc. | 04/29/1996SE |
| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
| K946000 | Abuscreen Online(R) CalibratorsDKJ · Traditional | Roche Diagnostic Systems, Inc. | 01/25/1995SE |
| K904301 | Du Pont Dimension(R) Salicylate(Sal) MethodDKJ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/09/1990SE |
| K902356 | Kodak Ektachem Clinical Chemistry Slides (Sali)DKJ · Traditional | Eastman Kodak Company | 07/16/1990SE |
| K882038 | GDS Enzymatic Salicylate ReagentDKJ · Traditional | Gds Technology, LLC | 06/24/1988SE |
| K873425 | Easy-Test Salicylate (Sal) #16691DKJ · Traditional | Em Diagnostic Systems, Inc. | 10/29/1987SE |
| K872321 | Emds Salicylate (Sal) Calibrator, No# 67641/93DKJ · Traditional | Em Diagnostic Systems, Inc. | 08/28/1987SE |
| K872330 | Emds Salicylate (Sal) Testpacks, Item No. 67694/95DKJ · Traditional | Em Diagnostic Systems, Inc. | 07/09/1987SE |
| K870336 | Salicylate Assay Kit, Catalogue Number 501-71DKJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 02/20/1987SE |
| K861615 | Salicylate Reagent SetDKJ · Traditional | Sterling Diagnostics, Inc. | 05/23/1986SE |
| K852027 | GGTP Reagent/Serum Iron/Salicylate Demand AnalyzerDKJ · Traditional | Advanced Biomedical Methods, Inc. | 05/29/1985SE |
| K844070 | TDX SalicylateDKJ · Traditional | Abbott Laboratories | 11/27/1984SE |
| K842158 | Salicylate Assay KitDKJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 10/22/1984SE |
| K843180 | Salicylate TestDKJ · Traditional | Sclavo, Inc. | 09/07/1984SE |
| K840243 | Determin. of Salicylate in Serum/PlastDKJ · Traditional | Sigma Chemical Co. | 03/23/1984SE |
| K833003 | Paramax Salicylate ReagentDKJ · Traditional | American Dade | 10/28/1983SE |
| K831336 | Salicylate Assay KitDKJ · Traditional | Quantimetrix Corp. | 07/07/1983SE |
| K823523 | Toxi-Lab Rapid ScreenDKJ · Traditional | Marion Laboratories, Inc. | 01/14/1983SE |
| K813431 | SalicylatesDKJ · Traditional | Bio-Analytics Laboratories, Inc. | 03/25/1982SE |
| K813185 | Salicylate Stat-PakDKJ · Traditional | Clin Tech Diagnostics Corp. | 11/24/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1648-2018 Class II | ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-2084-2017 Class II | Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | Beckman Coulter Inc. | 04/03/2017Terminated |
| Z-2884-2016 Class II | DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate…Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product… | Microgenics Corporation | 07/25/2016Terminated |
| Z-0323-2014 Class II | VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-2238-2009 | SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used…The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper… | Beckman Coulter Inc | 10/22/2007Terminated |
| Z-0361-2007 | Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear… | Diagnostic Chemicals, Ltd. | 12/05/2006Terminated |