The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Demand Ethyl Alcohol.
| Device ID | K854130 |
| 510k Number | K854130 |
| Device Name: | DEMAND ETHYL ALCOHOL |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Applicant | COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Carl Deaton |
| Correspondent | Carl Deaton COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | DIC |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-09 |
| Decision Date | 1985-11-05 |