Alcohol Control Materials
The Alcohol Control Materials are reference specimens containing known ethanol concentrations used to validate and verify the performance of alcohol testing methods in clinical toxicology and forensic laboratories. This device is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification requirements. It is regulated under 21 CFR 862.3280 within the Clinical Toxicology specialty.
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Basic Information
- Product Code
- DKC
- Device Class
- FDA class 1
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Jul 01, 2003 | Substantially Equivalent | Medical Analysis Systems, Inc. |
| K935819 | QUALITY CONTROL MATERIAL (ASSAYED) | Mar 22, 1994 | Substantially Equivalent | Columbia Diagnostics, Inc. |
| K933425 | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 | Nov 16, 1993 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL | Oct 27, 1993 | Substantially Equivalent | Beckman-Diagnostic Systems Group |
| K932067 | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III | Jun 16, 1993 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | Aug 12, 1991 | Substantially Equivalent | Cala Diagnostics |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | Jul 26, 1991 | Substantially Equivalent | Cala Diagnostics |
| K843872 | ETHANOL CONTROLS LOW & HIGH E5133/E5258 | Oct 31, 1984 | Substantially Equivalent | Sigma Chemical Co. |
| K833514 | TOXI CHEM SERUM ALCOHOL CONTROL | Dec 08, 1983 | Substantially Equivalent | Fisher Diagnostics |
| K810465 | EMIT-ST ETHYL ALCOHOL SERUM CONTROLS | Mar 06, 1981 | Substantially Equivalent | Syva Co. |
| K802618 | EMIT-STM ETHYL ALCOHOL URINE CONTROLS | Oct 31, 1980 | Substantially Equivalent | Syva Co. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.