Alcohol Calibrators
FDA 510(k) K853532 · Diagnostic Systems
510(k) numberK853532
Submission
- Device name
- Alcohol Calibrators
- Applicant
- Diagnostic Systems
Gibbstown, NJ, US - Received
- August 23, 1985
- Decision date
- September 16, 1985
- 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 |
| K882117 | Ethyl Alcohol StandardDNN · Traditional | Verichem Laboratories, Inc. | 08/04/1988SE |
| 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 |
|---|---|---|
| K905146 | Olympus Urine PHJQY · Traditional | 02/04/1991SE |
| K893691 | Emds Creatine Kinase Item Nimber 65411CGS · Traditional | 08/31/1989SE |
| K893692 | Emds Aspartate Aminotransferase Item Number 65405CIT · Traditional | 08/21/1989SE |
| K893966 | HDL Precipitating ReagentLBR · Traditional | 07/25/1989SE |
| K884993 | Visual Blood Glucose Test SystemCGA · Traditional | 12/29/1988SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | 06/20/1988SE |
| K880787 | Easy-Test Lactic Acid (la)KHP · Traditional | 03/15/1988SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | 07/11/1986SE |
| K854784 | Absorbance (Abs) Test PakJIT · Traditional | 12/19/1985SE |
| K853699 | Easy Analyzer & Easy-Test ReagentJJE · Traditional | 09/25/1985SE |
Questions and answers
When was Alcohol Calibrators cleared by the FDA?
Alcohol Calibrators (K853532) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 24 days after the submission was received.
What is the product code of K853532?
The FDA product code is DNN – Calibrators, Ethyl Alcohol, a Class II (moderate risk) device regulated under 21 CFR 862.3200.