Product code DKJ
- Device name
- Colorimetry, Salicylate
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3830
- Review panel
- TX
- 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 |
|---|---|---|---|
| K093939 | ADVIA CHEMISTRY SALICYLATE REAGENT | Siemens Healthcare Diagnostics | 2010-05-19 |
| K042329 | SALICYLATE-SL ASSAY | Diagnostic Chemicals , Ltd. | 2004-12-27 |
| K020794 | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-11 |
| K014173 | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | 2002-02-15 |
| K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | Syva Co. | 2001-08-13 |
| K981872 | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | Diagnostic Chemicals , Ltd. | 1998-06-29 |
| K980032 | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | Diagnostic Chemicals , Ltd. | 1998-03-02 |
| K964715 | PARAMAX SALICYLATE REAGENT | Dade Intl., Inc. | 1997-04-25 |
| K961131 | SALICYLATE ASSAY | Diagnostic Reagents, Inc. | 1996-04-29 |
| K951290 | AXSYM SALICYLATE | Abbott Laboratories | 1995-08-08 |
| K946000 | ABUSCREEN ONLINE(R) CALIBRATORS | Roche Diagnostic Systems, Inc. | 1995-01-25 |
| K904301 | DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-11-09 |
| K902356 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) | Eastman Kodak Company | 1990-07-16 |
| K882038 | GDS ENZYMATIC SALICYLATE REAGENT | Gds Technology, LLC | 1988-06-24 |
| K873425 | EASY-TEST SALICYLATE (SAL) #16691 | Em Diagnostic Systems, Inc. | 1987-10-29 |
| K872321 | EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 | Em Diagnostic Systems, Inc. | 1987-08-28 |
| K872330 | EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 | Em Diagnostic Systems, Inc. | 1987-07-09 |
| K870336 | SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 | Diagnostic Chemicals, Ltd. (Usa) | 1987-02-20 |
| K861615 | SALICYLATE REAGENT SET | Sterling Diagnostics, Inc. | 1986-05-23 |
| K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-05-29 |
| K844070 | TDX SALICYLATE | Abbott Laboratories | 1984-11-27 |
| K842158 | SALICYLATE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-10-22 |
| K843180 | SALICYLATE TEST | Sclavo, Inc. | 1984-09-07 |
| K840243 | DETERMIN. OF SALICYLATE IN SERUM/PLAST | Sigma Chemical Co. | 1984-03-23 |
| K833003 | PARAMAX SALICYLATE REAGENT | American Dade | 1983-10-28 |
| K831336 | SALICYLATE ASSAY KIT | Quantimetrix Corp. | 1983-07-07 |
| K823523 | TOXI-LAB RAPID SCREEN | Marion Laboratories, Inc. | 1983-01-14 |
| K813431 | SALICYLATES | Bio-Analytics Laboratories, Inc. | 1982-03-25 |
| K813185 | SALICYLATE STAT-PAK | Clin Tech Diagnostics Corp. | 1981-11-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414654256 | Atellica CH Salicylate (SalC) | Siemens Healthcare Diagnostics Inc. | 2025-10-15 |
| 07613336121504 | Salicyclate | Roche Diagnostics GmbH | 2020-03-05 |
| 00628063401123 | Salicylate Assay | SEKISUI DIAGNOSTICS, LLC | 2018-11-28 |
| 00380740135614 | Alinity | ABBOTT LABORATORIES | 2018-08-08 |
| 00630414595887 | Atellica CH Sal | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 00842768023347 | Emit® tox™ Salicylic Acid Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414498959 | ADVIA® Chemistry SAL Salicylate Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883001152 | DRI Salicylate Calibrator Kit | Microgenics Corporation | 2016-09-24 |
| 00842768015427 | Dimension Vista® Flex® reagent cartridge SAL | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005435 | Dimension® Flex® reagent cartridge SAL | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001611 | Syva® Emit® tox™ Salicylic Acid Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05055273209396 | SAL | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 00657498001011 | Salicylate Liqui-UV® | STANBIO LABORATORY, L.P. | 2016-09-23 |
| 04015630992256 | Salicylate | Roche Diagnostics GmbH | 2016-09-23 |
| 04015630915897 | Salicylate | Roche Diagnostics GmbH | 2016-09-20 |
| 00628063400867 | SALICYLATE-SL Assay | SEKISUI DIAGNOSTICS, LLC | 2016-09-16 |
| 00884883001145 | DRI Salicylate Serum Tox Assay | Microgenics Corporation | 2016-09-12 |
| 00380740005290 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740005306 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 10758750008773 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590222116 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |