The following data is part of a premarket notification filed by Esa, Inc. with the FDA for Model 5500 Coulochem Electrode Array System.
| Device ID | K931148 |
| 510k Number | K931148 |
| Device Name: | MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM |
| Classification | Chromatographic/fluorometric Method, Catecholamines |
| 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 | CHQ |
| CFR Regulation Number | 862.1165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-05 |
| Decision Date | 1993-06-09 |