The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Ethyl Alcohol Clinical Standard Solutions.
| Device ID | K990516 |
| 510k Number | K990516 |
| Device Name: | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
| Classification | Calibrators, Ethyl Alcohol |
| Applicant | EMD CHEMICALS INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EMD CHEMICALS INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | DNN |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 1999-03-31 |