Ethanol Controls Low & High E5133/E5258
FDA 510(k) K843872 · Sigma Chemical Co.
510(k) numberK843872
Submission
- Device name
- Ethanol Controls Low & High E5133/E5258
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- October 2, 1984
- Decision date
- October 31, 1984
- 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
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|---|---|---|---|
| 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 |
| K833514 | Toxi Chem Serum Alcohol ControlDKC · Traditional | Fisher Diagnostics | 12/08/1983SE |
| K810465 | Emit-St Ethyl Alcohol Serum ControlsDKC · Traditional | Syva Co. | 03/06/1981SE |
| K802618 | Emit-Stm Ethyl Alcohol Urine ControlsDKC · Traditional | Syva Co. | 10/31/1980SE |
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| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
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Questions and answers
When was Ethanol Controls Low & High E5133/E5258 cleared by the FDA?
Ethanol Controls Low & High E5133/E5258 (K843872) received a 510(k) decision of Substantially Equivalent on October 31, 1984, 29 days after the submission was received.
What is the product code of K843872?
The FDA product code is DKC – Alcohol Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.