Emit-St Ethyl Alcohol Serum Controls
FDA 510(k) K810465 · Syva Co.
510(k) numberK810465
Submission
- Device name
- Emit-St Ethyl Alcohol Serum Controls
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- February 23, 1981
- Decision date
- March 6, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKC – Alcohol Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031392 | Mas Tox Ammonia Controlliquid Assayed Tox Ammonia ControlDKC · Traditional | Medical Analysis Systems, Inc. | 07/01/2003SE |
| K935819 | Quality Control Material (Assayed)DKC · Traditional | Columbia Diagnostics, Inc. | 03/22/1994SE |
| K933425 | Ammonia/Ethanol Controls, High/Low, Cat.# A7937/7812DKC · Traditional | Sigma Diagnostics, Inc. | 11/16/1993SE |
| K934467 | Beckman CX Ammonia/Alcohol ControlDKC · Traditional | Beckman-Diagnostic Systems Group | 10/27/1993SE |
| K932067 | Ethanol Controls, Urine, Levels 1,II, and IIIDKC · Traditional | Sigma Diagnostics, Inc. | 06/16/1993SE |
| K912827 | Serum Alcohol Control Levels 1, 2 & 3DKC · Traditional | Cala Diagnostics | 08/12/1991SE |
| K912826 | Whole Blood Alcohol Control, Level 1 & 2DKC · Traditional | Cala Diagnostics | 07/26/1991SE |
| K843872 | Ethanol Controls Low & High E5133/E5258DKC · Traditional | Sigma Chemical Co. | 10/31/1984SE |
| K833514 | Toxi Chem Serum Alcohol ControlDKC · Traditional | Fisher Diagnostics | 12/08/1983SE |
| K802618 | Emit-Stm Ethyl Alcohol Urine ControlsDKC · Traditional | Syva Co. | 10/31/1980SE |
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| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
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Questions and answers
When was Emit-St Ethyl Alcohol Serum Controls cleared by the FDA?
Emit-St Ethyl Alcohol Serum Controls (K810465) received a 510(k) decision of Substantially Equivalent on March 6, 1981, 11 days after the submission was received.
What is the product code of K810465?
The FDA product code is DKC – Alcohol Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.