The following data is part of a premarket notification filed by Esa, Inc. with the FDA for Model 5500 Ceas.
| Device ID | K963938 |
| 510k Number | K963938 |
| Device Name: | MODEL 5500 CEAS |
| Classification | Chromatographic/fluorometric Method, Catecholamines |
| Applicant | ESA, INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Contact | James Mayol |
| Correspondent | James Mayol ESA, INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Product Code | CHQ |
| CFR Regulation Number | 862.1165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-01 |
| Decision Date | 1996-12-26 |