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 | K981926 |
510k Number | K981926 |
Device Name: | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
Classification | Calibrators, Drug Specific |
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 | DLJ |
CFR Regulation Number | 862.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-02 |
Decision Date | 1998-07-22 |
Summary: | summary |