Ammonia/Ethanol Controls, High/Low, Cat.# A7937/7812
FDA 510(k) K933425 · Sigma Diagnostics, Inc.
510(k) numberK933425
Submission
- Device name
- Ammonia/Ethanol Controls, High/Low, Cat.# A7937/7812
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- July 13, 1993
- Decision date
- November 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| 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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Questions and answers
When was Ammonia/Ethanol Controls, High/Low, Cat.# A7937/7812 cleared by the FDA?
Ammonia/Ethanol Controls, High/Low, Cat.# A7937/7812 (K933425) received a 510(k) decision of Substantially Equivalent on November 16, 1993, 126 days after the submission was received.
What is the product code of K933425?
The FDA product code is DKC – Alcohol Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.