DKC — Alcohol Control Materials Class I
FDA product code DKC covers "Alcohol Control Materials", a Class I medical device regulated under 21 CFR 862.3280. Submissions are reviewed by the Clinical Toxicology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DKC
- Device Class
- Class I
- Regulation Number
- 862.3280
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K031392 | medical analysis systems | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | July 1, 2003 |
| K935819 | columbia diagnostics | QUALITY CONTROL MATERIAL (ASSAYED) | March 22, 1994 |
| K933425 | sigma diagnostics | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 | November 16, 1993 |
| K934467 | beckman-diagnostic systems group | BECKMAN CX AMMONIA/ALCOHOL CONTROL | October 27, 1993 |
| K932067 | sigma diagnostics | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III | June 16, 1993 |
| K912827 | cala diagnostics | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | August 12, 1991 |
| K912826 | cala diagnostics | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | July 26, 1991 |
| K843872 | sigma chemical | ETHANOL CONTROLS LOW & HIGH E5133/E5258 | October 31, 1984 |
| K833514 | fisher diagnostics | TOXI CHEM SERUM ALCOHOL CONTROL | December 8, 1983 |
| K810465 | syva | EMIT-ST ETHYL ALCOHOL SERUM CONTROLS | March 6, 1981 |
| K802618 | syva | EMIT-STM ETHYL ALCOHOL URINE CONTROLS | October 31, 1980 |