On.Site Alcohol
FDA 510(k) K963197 · Ansys, Inc.
510(k) numberK963197
Submission
- Device name
- On.Site Alcohol
- Applicant
- Ansys, Inc.
Irvine, CA, US - Received
- August 15, 1996
- Decision date
- September 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DML
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013538 | EthanolDML · Traditional | Abbott Laboratories | 12/14/2001SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | Syva Co. | 02/01/2000SE |
| K953765 | Axsym Rea EthanolDML · Traditional | Abbott Laboratories | 09/27/1995SE |
| K952839 | Boehringer Mannheim Ethyl Alcohol AssayDML · Traditional | Boehringer Mannheim Corp. | 08/24/1995SE |
| K923337 | On*Site AlcoholDML · Traditional | Toxi-Lab, Inc. | 01/12/1993SE |
| K914777 | Sigma Procedure No. 333-UVDML · Traditional | Sigma Diagnostics, Inc. | 12/27/1991SE |
| K874382 | Raichem(Tm) Alcohol ReagentDML · Traditional | Reagents Applications, Inc. | 01/11/1988SE |
| K872180 | Kinetic 610 EthanolDML · Traditional | American Monitor Corp. | 07/07/1987SE |
| K863419 | Emds(Tm) Alcohol Testpacks, #67691/95DML · Traditional | Em Diagnostic Systems, Inc. | 09/29/1986SE |
| K840769 | Paramax Alcohol ReagentDML · Traditional | American Dade | 04/13/1984SE |
Questions and answers
When was On.Site Alcohol cleared by the FDA?
On.Site Alcohol (K963197) received a 510(k) decision of Substantially Equivalent on September 19, 1996, 35 days after the submission was received.
What is the product code of K963197?
The FDA product code is DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.