DKJ — Colorimetry, Salicylate Class II
FDA product code DKJ covers "Colorimetry, Salicylate", a Class II medical device regulated under 21 CFR 862.3830. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DKJ
- Device Class
- Class II
- Regulation Number
- 862.3830
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093939 | siemens healthcare diagnostics | ADVIA CHEMISTRY SALICYLATE REAGENT | May 19, 2010 |
| K042329 | diagnostic chemicals | SALICYLATE-SL ASSAY | December 27, 2004 |
| K020794 | bayer diagnostics | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | July 11, 2002 |
| K014173 | beckman coulter | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | February 15, 2002 |
| K011878 | syva | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA | August 13, 2001 |
| K981872 | diagnostic chemicals | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | June 29, 1998 |
| K980032 | diagnostic chemicals | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | March 2, 1998 |
| K964715 | dade intl | PARAMAX SALICYLATE REAGENT | April 25, 1997 |
| K961131 | diagnostic reagents | SALICYLATE ASSAY | April 29, 1996 |
| K951290 | abbott laboratories | AXSYM SALICYLATE | August 8, 1995 |
| K946000 | roche diagnostic systems | ABUSCREEN ONLINE(R) CALIBRATORS | January 25, 1995 |
| K904301 | e.i. dupont de nemours and co | DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD | November 9, 1990 |
| K902356 | eastman kodak | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) | July 16, 1990 |
| K882038 | gds technology | GDS ENZYMATIC SALICYLATE REAGENT | June 24, 1988 |
| K873425 | em diagnostic systems | EASY-TEST SALICYLATE (SAL) #16691 | October 29, 1987 |
| K872321 | em diagnostic systems | EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 | August 28, 1987 |
| K872330 | em diagnostic systems | EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 | July 9, 1987 |
| K870336 | diagnostic chemicals, ltd. (usa) | SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 | February 20, 1987 |
| K861615 | sterling diagnostics | SALICYLATE REAGENT SET | May 23, 1986 |
| K852027 | advanced biomedical methods | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | May 29, 1985 |