DKJ — Colorimetry, Salicylate Class II
FDA Device Classification
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 |