Emds(Tm) Alcohol Testpacks, #67691/95
FDA 510(k) K863419 · Em Diagnostic Systems, Inc.
510(k) numberK863419
Submission
- Device name
- Emds(Tm) Alcohol Testpacks, #67691/95
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- September 3, 1986
- Decision date
- September 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K963197 | On.Site AlcoholDML · Traditional | Ansys, Inc. | 09/19/1996SE |
| 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 |
| K840769 | Paramax Alcohol ReagentDML · Traditional | American Dade | 04/13/1984SE |
More from American Dade
| 510(k) | Device | Decision |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Emds(Tm) Alcohol Testpacks, #67691/95 cleared by the FDA?
Emds(Tm) Alcohol Testpacks, #67691/95 (K863419) received a 510(k) decision of Substantially Equivalent on September 29, 1986, 26 days after the submission was received.
What is the product code of K863419?
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.