DKJ · Colorimetry, Salicylate
Clinical Toxicology · 21 CFR 862.3830 · Class 2
Overview
| Product Code | DKJ |
|---|---|
| Device Name | Colorimetry, Salicylate |
| Regulation | 21 CFR 862.3830 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093939 | ADVIA CHEMISTRY SALICYLATE REAGENT | Siemens Healthcare Diagnostics | May 19, 2010 | SESE |
| K042329 | SALICYLATE-SL ASSAY | Diagnostic Chemicals , Ltd. | Dec 27, 2004 | SESE |
| K020794 | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Jul 11, 2002 | SESE |
| K014173 | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | Feb 15, 2002 | SESE |
| K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | Syva Co. | Aug 13, 2001 | SESE |
| K981872 | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | Diagnostic Chemicals , Ltd. | Jun 29, 1998 | SESE |
| K980032 | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | Diagnostic Chemicals , Ltd. | Mar 2, 1998 | SESE |
| K964715 | PARAMAX SALICYLATE REAGENT | Dade Intl., Inc. | Apr 25, 1997 | SESE |
| K961131 | SALICYLATE ASSAY | Diagnostic Reagents, Inc. | Apr 29, 1996 | SESE |
| K951290 | AXSYM SALICYLATE | Abbott Laboratories | Aug 8, 1995 | SESE |
| K946000 | ABUSCREEN ONLINE(R) CALIBRATORS | Roche Diagnostic Systems, Inc. | Jan 25, 1995 | SESE |
| K904301 | DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Nov 9, 1990 | SESE |
| K902356 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) | Eastman Kodak Company | Jul 16, 1990 | SESE |
| K882038 | GDS ENZYMATIC SALICYLATE REAGENT | Gds Technology, LLC | Jun 24, 1988 | SESE |
| K873425 | EASY-TEST SALICYLATE (SAL) #16691 | Em Diagnostic Systems, Inc. | Oct 29, 1987 | SESE |
| K872321 | EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 | Em Diagnostic Systems, Inc. | Aug 28, 1987 | SESE |
| K872330 | EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 | Em Diagnostic Systems, Inc. | Jul 9, 1987 | SESE |
| K870336 | SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 | Diagnostic Chemicals, Ltd. (Usa) | Feb 20, 1987 | SESE |
| K861615 | SALICYLATE REAGENT SET | Sterling Diagnostics, Inc. | May 23, 1986 | SESE |
| K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | May 29, 1985 | SESE |
Top Applicants
- Diagnostic Chemicals , Ltd. — 3 clearances
- Em Diagnostic Systems, Inc. — 3 clearances
- Abbott Laboratories — 2 clearances
- Diagnostic Chemicals, Ltd. (Usa) — 2 clearances
- Advanced Biomedical Methods, Inc. — 1 clearance
