Ethyl Alcohol Calibrators & Control
FDA 510(k) K924733 · Diagnostic Reagents, Inc.
510(k) numberK924733
Submission
- Device name
- Ethyl Alcohol Calibrators & Control
- Applicant
- Diagnostic Reagents, Inc.
Mountain View, CA, US - Received
- September 22, 1992
- Decision date
- December 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K882117 | Ethyl Alcohol StandardDNN · Traditional | Verichem Laboratories, Inc. | 08/04/1988SE |
| 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 |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
Questions and answers
When was Ethyl Alcohol Calibrators & Control cleared by the FDA?
Ethyl Alcohol Calibrators & Control (K924733) received a 510(k) decision of Substantially Equivalent on December 9, 1992, 78 days after the submission was received.
What is the product code of K924733?
The FDA product code is DNN – Calibrators, Ethyl Alcohol, a Class II (moderate risk) device regulated under 21 CFR 862.3200.