The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Serotonin Enzyme Immunoassay.
| Device ID | K903609 |
| 510k Number | K903609 |
| Device Name: | SEROTONIN ENZYME IMMUNOASSAY |
| Classification | Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin |
| Applicant | IMMUNOTECH CORP. 130, AVENUE JEAN DE LATTRE DE TASSIGNY-BP 177, 13276 MARSEIL Cedex 9 (france), FR |
| Contact | Rickenberg |
| Correspondent | Rickenberg IMMUNOTECH CORP. 130, AVENUE JEAN DE LATTRE DE TASSIGNY-BP 177, 13276 MARSEIL Cedex 9 (france), FR |
| Product Code | CDA |
| CFR Regulation Number | 862.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-09 |
| Decision Date | 1990-10-22 |