Ethyl Alcohol Standard
FDA 510(k) K882117 · Verichem Laboratories, Inc.
510(k) numberK882117
Submission
- Device name
- Ethyl Alcohol Standard
- Applicant
- Verichem Laboratories, Inc.
Providence, RI, US - Received
- May 19, 1988
- Decision date
- August 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DNN – Calibrators, Ethyl Alcohol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990516 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | Emd Chemicals, Inc. | 03/31/1999SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | Emd Chemicals, Inc. | 10/01/1997SE |
| K924733 | Ethyl Alcohol Calibrators & ControlDNN · Traditional | Diagnostic Reagents, Inc. | 12/09/1992SE |
| K853532 | Alcohol CalibratorsDNN · Traditional | Diagnostic Systems | 09/16/1985SE |
| K810466 | Ethyl Alcohol Serum CalibratorDNN · Traditional | Syva Co. | 03/06/1981SE |
| K802620 | Emit-Stm Ethyl Alcohol Urine CalibratorDNN · Traditional | Syva Co. | 10/31/1980SE |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | 03/28/2012SE |
| K974290 | Microprotein Standard KitJIX · Traditional | 12/19/1997SE |
| K973345 | Matrix Plus Multi-Calibrator KitJIX · Traditional | 10/29/1997SE |
| K972333 | Ammonia/Iron Standard KitJIX · Traditional | 07/23/1997SE |
| K924904 | Hdl-Cholesterol Standard, ModificationJIS · Traditional | 01/13/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | 07/19/1991SE |
| K901113 | Matrix Plus(Tm) Chemistry Reference StandardJIS · Traditional | 03/29/1990SE |
| K882059 | Bilirubin StandardJIT · Traditional | 10/25/1988SE |
| K881320 | Urine Toxicology StandardDKB · Traditional | 09/09/1988SE |
| K875285 | Multi-Chemistry Linearity StandardJIX · Traditional | 09/02/1988SE |
Questions and answers
When was Ethyl Alcohol Standard cleared by the FDA?
Ethyl Alcohol Standard (K882117) received a 510(k) decision of Substantially Equivalent on August 4, 1988, 77 days after the submission was received.
What is the product code of K882117?
The FDA product code is DNN – Calibrators, Ethyl Alcohol, a Class II (moderate risk) device regulated under 21 CFR 862.3200.