The following data is part of a premarket notification filed by Esa, Inc. with the FDA for Coulochem Ii.
| Device ID | K903231 |
| 510k Number | K903231 |
| Device Name: | COULOCHEM II |
| Classification | Detectors, Electrochemical, Liquid Chromatography |
| Applicant | ESA, INC. 45 WIGGINS AVE. Bedford, MA 01730 |
| Contact | Prentiss C Higgins |
| Correspondent | Prentiss C Higgins ESA, INC. 45 WIGGINS AVE. Bedford, MA 01730 |
| Product Code | LEQ |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-23 |
| Decision Date | 1990-09-27 |